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

Model Number ADAPTAO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Visual Impairment (2138); Eye Pain (4467)

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 319477021
• Report Number: 0001313525-2023-70090
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 10757770485731
• UDI-Public: (01)10757770485731(17)250930
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ADAPTAO
• Device Catalogue Number: ADAPTAOP0700
• Device Lot Number: 1269920
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female