MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS SINGLE USE INSERTION DEVICE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number	AI-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Red Eye(s) (2038); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an uncomplicated intraocular lens (iol) implantation in the left eye, the patient presented with decreased visual acuity, red eye, positive tyndal's and suspected tass.Five (5) days post procedure, a secondary intervention was performed at another healthcare facility and the iol was explanted and replaced with an unknown iol.Additional information was requested, but not received.
Additional Manufacturer Narrative
Although requested, the device was not returned.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.Based on the available information, the root cause of this event could not be determined.
Event or Problem Description
Additional information was received.We were informed the patient is fine and additional information is not available.
Additional Manufacturer Narrative
Updated b5, d4, g3, g6, h2, h6 and h11.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.

• Brand Name: AKREOS SINGLE USE INSERTION DEVICE
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 21 north park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22335617
• Report Number: 0001313525-2025-00137
• Device Sequence Number: 9126601
• Product Code: MSS
• UDI-Device Identifier: 00757770473946
• UDI-Public: (01)00757770473946(17)251004(11)241004(10)H2427502
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 10/04/2025
• Device Model Number: AI-28
• Device Lot Number: H2427502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AKREOS IOL, AMVISC, BSS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male