RegWardenFDA facility compliance records
Facility

OptiMedica Corp.

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

Activity by year

FDA actions on record by year2018: 3 recalls; 2019: 1 recalls; 2021: 2 recalls; 2022: 4 recalls; 2023: 3 recalls; 2024: 1 recalls; 2026: 1 recalls20173201812019202022021420223202312024202512026
  • Recalls (15)

Devices registered here (1)

Recalls & enforcement

20261 record
  • Class IIOngoing2026-07-31
    Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) befor…
20241 record
  • Class IIOngoing2024-03-14
    Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
20233 records
  • Class IIOngoing2023-12-12
    Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
  • Class IIOngoing2023-07-06
    Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
  • Class IIOngoing2023-05-30
    Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surg…
20224 records
  • Class IIOngoing2022-12-07
    Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result …
  • Class IIOngoing2022-09-07
    Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability…
  • Class IIOngoing2022-09-01
    As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
  • Class IIOngoing2022-04-06
    Potential breach in the sterility barrier for tray ring covers.
20212 records
  • Class IITerminated2021-08-06
    Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additio…
  • Class IITerminated2021-01-27
    Due to the release of nonconforming Intraocular Lenses (IOLs).
20191 record
  • Class IITerminated2019-12-03
    Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular inju…
20183 records
  • Class IITerminated2018-09-24
    Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.
  • Class IITerminated2018-06-21
    Expired intraocular lenses were distributed.
  • Class IITerminated2018-05-09
    Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.

Related

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. “OptiMedica Corp. (FEI 3005675890) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005675890-optimedica-corp/

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