MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB IOL INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number	INJ100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded.Investigation of this event is ongoing.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Reportedly, the surgeon discovered a broken haptic after implantation of an intraocular lens.The lens was removed intraoperatively.A replacement lens of the same diopter was implanted 1-week postop.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h4, h6, h10 corrected data: h6 the device was discarded.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined; however; user-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have caused or contributed to the event.

• Brand Name: BAUSCH + LOMB IOL INJECTOR
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 7277246600
• MDR Report Key: 17240203
• Report Number: 0001313525-2023-70082
• Device Sequence Number: 6831526
• Product Code: MSS
• UDI-Device Identifier: 00757770505326
• UDI-Public: (01)00757770505326(17)250228(10)22136A5
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K113852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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 Expiration Date: 02/28/2025
• Device Model Number: INJ100
• Device Lot Number: 22136A5
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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 TORIC INTRAOCULAR LENS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown