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

Model Number	MX60PT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227); Excessive Tear Production (2235)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the consumer that one day after implantation of an intraocular lens (iol) into the right eye (od), they experienced a change in color perception, watery eye that felt heavy, and blurry vision.Allegedly, the antibiotic used by the surgeon caused worm like shadows causing obstruction of view on the right outer side.The surgeon indicated all measurements looked good, however five months after implantation, a successful lens exchange using a different model lens was completed.Additional information has been requested of the reporter, but not received.
Additional Manufacturer Narrative
Per the reporter, the device is not available for evaluation.Additional information has been requested of the reporter, but not received.The device history record (dhr) review did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information provided, a root cause could not be conclusively determined.
Additional Manufacturer Narrative
Additional information received indicating the device causality was unrelated, and therefore, this event no longer meets reportability requirements.
Event or Problem Description
Additional information was received indicating an unvalidated injector was used to complete this surgery.Also the outcome according to the surgeon was subjective and there was no issues reported with the lens.It is noteworthy to mention that the replacement iol was of a different model and diopter.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; 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: 16918739
• Report Number: 0001313525-2023-70052
• Device Sequence Number: 12490170
• Product Code: MJP
• UDI-Device Identifier: 10757770566508
• UDI-Public: (01)10757770566508(17)250630
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 06/30/2025
• Device Model Number: MX60PT
• Device Catalogue Number: MXUPT125+240
• Device Lot Number: 3257017
• 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: 05/12/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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: Female