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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation as it was discarded.The investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
It was reported that the leading haptic broke off when inserting the intraocular lens (iol) into the eye.The haptic remained in the injector chamber.The lens was cut and the incision was enlarged to remove the lens.Another lens with the same model and diopter was successfully implanted.There was no patient impact.
Additional Manufacturer Narrative
As a lot number for the device was not provided, the associated device history record (dhr) was not reviewed.The 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 determined.

• 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 ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17245630
• Report Number: 0001313525-2023-70083
• Device Sequence Number: 17850270
• Product Code: MSS
• UDI-Device Identifier: 00757770505326
• UDI-Public: (01)00757770505326
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/07/2023

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 Model Number: INJ100
• Was Device Available for Evaluation?: No
• 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: 07/03/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 IOL, EYEFILL C.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown