Facility

FCI OPHTHALMICS, INC.

16 recall(s) on record — most severe on record: Class II.

Key facts

16recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3000210020
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	30 Corporate Park Drive Pembroke, MA, US 02359
Registration status	Active · expires 2026
Parent company	Carl Zeiss Meditec AG (Jena) (owner-operator 9053564)
Brand names	Morcher CTR

Activity by year

Recalls (16)

Devices registered here (1)

Ring, Endocapsular
Product code MRJ (opens in a new tab) · Class III · Unknown

Recalls & enforcement

20261 record

Class IIOngoing2026-06-01
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

20222 records

Class IIOngoing2022-03-16
High friction of the slider can cause the device to stick, or not move as intended.
Class IIOngoing2022-01-14
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

20211 record

Class IIOngoing2021-07-08
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.

20202 records

Class IITerminated2020-12-07
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Class IITerminated2020-08-06
Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potent…

20183 records

Class IITerminated2018-12-06
VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occu…
Class IITerminated2018-10-16
Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.
Class IITerminated2018-06-25
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.

20171 record

Class IITerminated2017-08-30
The device had an incorrect printed calibration value on the calibration certificate.

20152 records

Class IITerminated2015-10-27
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Class IITerminated2015-01-22
Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.

20141 record

Class IITerminated2014-02-03
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

20132 records

Class IITerminated2013-10-23
The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wr…
Class IITerminated2013-04-18
Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.

20121 record

Class IITerminated2012-10-25
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “FCI OPHTHALMICS, INC. (FEI 3000210020) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000210020-fci-ophthalmics-inc/

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