BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
Received May 1, 2026 · Event occurred Mar 27, 2026
Report 0001313525-2026-00042 · MDR key 25057701
Device
Generic name
Folders And Injectors, Intraocular Lens (iol)
Manufacturer
Bausch + LombModel number
BLIS-X1Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
THE HEALTHCARE FACILITY REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AFTER ACCIDENTAL RUPTURE OF THE POSTERIOR CAPSULE FOLLOWING ASPIRATION OF THE CRYSTALLINE LENS CORTEX. WHEN THE LENS WAS INJECTED INTO THE EYE IT WAS NOTED THAT THERE WAS A CUT AT THE EDGE OF THE LENS OPTIC AND A HAPTIC WAS MISSING. THE INCISION WAS ENLARGED FOR REMOVAL OF THE LENS, AND SEVERAL CORNEAL SUTURES WERE USED TO CLOSE THE INCISION. AS A SUITABLE LENS WAS NOT AVAILABLE THE PATIENT WAS LEFT APHAKIA.
Additional Manufacturer Narrative
INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B4, G3, G6, H2, H6 AND H11. ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS A LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THE ASSOCIATED DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED. BASED ON THE AVAILABLE INFORMATION THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, MANUFACTURING RELATED FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. BAUSCH + LOMB WILL CONTINUE TO MONITOR SIMILAR OCCURRENCES.