Facility

CIBA VISION JOHOR SDN.BHD.,

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

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	3006466212
Establishment type	Manufacture Medical Device; Repack or Relabel Medical Device
Location	NO.1, JALAN DPB/5 GELANG PATAH, JOHOR DARUL TAKZIM, MY 81560
Registration status	Active · expires 2026
Parent company	Alcon Laboratories, Inc. (owner-operator 1610287)

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Lenses, Soft Contact, Extended Wear
Product code LPM (opens in a new tab) · Class III · Ophthalmic · 21 CFR 886.5925

Recalls & enforcement

Class IITerminated2018-07-17
Potential for the optical head to detach from the stand due to the lack of thread adhesive.

FDA inspections (1)

VAI2016-11-17
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “CIBA VISION JOHOR SDN.BHD., (FEI 3006466212) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006466212-ciba-vision-johor-sdn-bhd/

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