MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA ASPIRE IOL; INTRAOCULAR LENS

Model Number	EA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Eye Pain (4467)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and therefore not available for evaluation.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, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.The biometry values for surgeon factor and acd constant lens calculations were found to be transposed.Corrections were made.Bausch + lomb will continue to monitor such events.
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol) into the left eye (os), the patient complained of blurry vision to the point of pain.A successful lens exchange was performed two weeks after initial implant using the same model, different diopter iol.In the surgeon's opinion, the most likely cause of the event was the values for the surgeon factor and acd constant.Once corrections were made, the proper lens power was chosen & worked perfectly after lens exchange.The patient's outcome was good.

• Brand Name: ENVISTA ASPIRE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 20682969
• Report Number: 0001313525-2024-00168
• Device Sequence Number: 18288577
• Product Code: HQL
• UDI-Device Identifier: 10757770608444
• UDI-Public: (01)10757770608444(17)261031(11)231118(10)3P31459
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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: EA
• Device Catalogue Number: EAU1450
• Device Lot Number: 3P31459
• 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: 08/14/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female