MAUDE Adverse Event Report: BAUSCH + LOMB IC-8 APTHERA IOL; INTRAOCULAR LENS

Model Number	IC8APT+220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection found the lens had the appearance of the reported lens and was missing one haptic.The center of the optic was cut, and there was a portion of the optic missing near the second haptic-optic junction.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
It was reported that during the placement of an intraocular lens, the lens tore at the haptic junction.After implantation into the eye, the lens was removed and a back up lens of the same model and diopter was attempted.The back up lens implantation was not successful and the iris was torn during the removal of the back up lens.The patient was left aphakic.Additional information has been requested of the reporter, but has not been provided.Lens 2 of 2.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h6, h10/11 a review of the device history record (dhr), did not find any anomalies or nonconformities related to the reported event.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have contributed to the event.

• Brand Name: IC-8 APTHERA IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 16967013
• Report Number: 0001313525-2023-70057
• Device Sequence Number: 5491898
• Product Code: HQL
• UDI-Device Identifier: 00813359020977
• UDI-Public: (01)00813359020977(17)230509(11)220510(10)BE-GA-22013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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 Model Number: IC8APT+220
• Device Catalogue Number: 82078-220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• 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: 05/19/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 76 YR
• Patient Sex: Female