MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	MX60TP200+205
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Codes	Eye Injury (1845); Vitreous Loss (2142)
Date of Event	09/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly an intraocular lens was slow to open and was stiff once placed in the patient eye.The surgeon rotated the lens to the correct position in the eye which caused the leading haptic to nick some of the lens zonules leading to vitreous escaping through the main incision and side ports.The surgeon cut the vitreous with scissors and the patient was given oral diamox and alphagan drops just after surgery.Patient condition was satisfactory at the time of reporting.
Additional Manufacturer Narrative
The device remains implanted in the patient and is not available for evaluation.Investigation of this event is ongoing.A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The iol was not returned for evaluation.A review of the device history record did not identify any anomalies or nonconformities that could be related to this event.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 determined, however, it is noteworthy to mention that the injector used to complete this procedure was not validated for use with this iol.
Event or Problem Description
Additional information was received indicating a competitor inject tor was used to complete this procedure.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17854740
• Report Number: 0001313525-2023-70112
• Device Sequence Number: 6683579
• Product Code: MJP
• UDI-Device Identifier: 10757770517128
• UDI-Public: (01)10757770517128(17)250531
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2023

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: 05/31/2025
• Device Model Number: MX60TP200+205
• Device Catalogue Number: MX60TP200+205
• Device Lot Number: 3254510
• Was Device Available for Evaluation?: No
• 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: 10/02/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown