MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS ADAPTAO INTRAOCULAR LENS

Model Number	ADAPTAO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Visual Impairment (2138); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that, one week after implantation of an iol, a patient was found to have visual acuity loss, eye pain, conjunctival congestion, and edema, which was later diagnosed as endophthalmitis.After hospitalization, the symptoms improved, the vision recovered, and the patient was discharged.10 days post-discharge a re-examination of the patient showed a recurrence of endophthalmitis.The patient was referred to another hospital for further diagnosis and treatment.
Additional Manufacturer Narrative
Although requested, additional information regarding the event was not provided and the lens was not returned for investigation.A device history record (dhr) review did not find any non-conformities or anomalies related to this event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the information provided, a root cause could not be determined.

• Brand Name: AKREOS ADAPTAO INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n. park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17365172
• Report Number: 0001313525-2023-70090
• Device Sequence Number: 12063583
• Product Code: HQL
• UDI-Device Identifier: 10757770485731
• UDI-Public: (01)10757770485731(17)250930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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: 09/30/2025
• Device Model Number: ADAPTAO
• Device Catalogue Number: ADAPTAOP0700
• Device Lot Number: 1269920
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female