KAMRA inlay 76225-10Recalls & reported problems
Bausch & Lomb Incorporated · Carton Assy, US, KAMRA Pod, Dispenser Carton Assembly · Class 3 · Implant
All models of KAMRA inlay (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813359020052), received between Aug 11, 2017 and Oct 12, 2017 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
Patient problems
- Corneal Infiltrates1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 12, 2017No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM A FEMALE PATIENT DUE TO AN INFILTRATE ADJACENT TO THE INLAY.
Patient problems: Corneal Infiltrates
MAUDE report 6946270 ↗InjuryAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6)YEAR OLD MALE PATIENT AT THE PATIENT'S REQUEST APPROXIMATELY 14 DAYS POSTOPERATIVELY DUE TO PERSISTENT COMPLAINTS OF POOR NEAR AND DISTANCE VISION.
Patient problems: Visual Impairment
MAUDE report 6790287 ↗
Other Implant, Corneal, Refractive devices
- Raindrop Near Vision Inlay RD1-1Revision Optics, Inc. · Implant, Corneal, Refractive154 reports
- KAMRA inlay 76043Bausch & Lomb Incorporated · Implant, Corneal, Refractive27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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