Bausch + Lomb AI-28Recalls & reported problems
Bausch & Lomb Incorporated · Inserter · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00757770473946), received between Sep 17, 2024 and Jun 26, 2025 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Corneal Edema1
- Loss of Vision1
- No Clinical Signs, Symptoms or Conditions1
- Red Eye(s)1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING AN UNCOMPLICATED INTRAOCULAR LENS (IOL) IMPLANTATION IN THE LEFT EYE, THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY, RED EYE, POSITIVE TYNDAL'S AND SUSPECTED TASS. FIVE (5) DAYS POST PROCEDURE, A SECONDARY INTERVENTION WAS PERFORMED AT ANOTHER HEALTHCARE FACILITY AND THE IOL WAS EXPLANTED AND REPLACED WITH AN UNKNOWN IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Red Eye(s); Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 22335617 ↗InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, AFTER IMPLANTATION OF AN IOL TWO LARGE CRACKS WERE OBSERVED ACROSS THE CENTER. THE IOL WAS REMOVED EXTENDING THE SURGERY TIME. A REPLACEMENT LENS WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions
MAUDE report 21231400 ↗InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE THE LENS SPLIT IN THE CENTRE AND AN UNKNOWN LENS WAS USED TO COMPLETE THE PROCEDURE. INCISION WAS ENLARGED AND SUTURES WERE USED TO COMPLETE THE PROCEDURE. REPORTEDLY THE PATIENT HAS SUFFERED IRREVERSIBLE CORNEAL ENDOTHELIAL DAMAGE RESULTING IN CORNEAL EDEMA AND ADDITIONAL COMPLICATIONS INCLUDING VISION LOSS. SUBSEQUENTLY PENETRATING KERATOPLASTY AND PUPILLOPLASTY PROCEDURES WERE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Corneal Edema; Loss of Vision
MAUDE report 20238363 ↗
Other Lens, Guide, Intraocular devices
- MONARCH® III 8065977763Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR1 recall1,042 reports
- UNFOLDER PLATINUM 1 SERIES 1MTEC30Johnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR524 reports
- MONARCH® III 8065977773Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR338 reports
- UNFOLDER EMERALD EMERALDCJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR250 reports
- UNFOLDER SILVER PSCSTJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR66 reports
- MONARCH® II 8065977758Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR22 reports
- UNFOLDER EMERALD EMERALDTJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR8 reports
- ONE SERIES ULTRA 1VIPR30Johnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR8 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page