MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA SIMPLIFEYE INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS

Model Number	21987
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for return.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history trend analysis and direction for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause could not be conclusively determined.
Event or Problem Description
A hospital reported that on day 2, following an uncomplicated intraocular lens (iol) implantation the patient presented with corneal edema.The edema was treated with dexafree (dexaméthason) eye drop, indocollyre (indometacin), odm5 (sodium hyaluronate) eye drops and geltim (timolol) via ocular route.A broken haptic was discovered in the anterior chamber.Approximately 11 weeks post implantation the patient was rehospitalized and a different surgeon explanted the original iol, removed the broken haptic and another lens was placed in the eye.Before the original surgery, the va was 5f/10 p5.Two days post-surgery the va was: 3/10 p6.The va was not quantifiable at one-month post-surgery.No va available post revision.Additional information has been requested.

• Brand Name: ENVISTA SIMPLIFEYE INJECTOR
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; alternhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22508272
• Report Number: 0001313525-2025-00150
• Device Sequence Number: 8736212
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)261031(10)2304E9
• Combination Product (Y/N): N
• PMA/510(K) Number: K192005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 21987
• Device Lot Number: 2304E9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENVISTA PRELOADED TORIC IOL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown