MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON PMMA SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	CZ70BD
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pharmacist reported during the posterior vitrectomy surgery plus phacoemulsification and intraocular lens insertion in the left eye surgeon evidences narrowing in the insertion site, which causes damage to the optics.The surgery was completed on the same day by using a back up device without complications.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.A dark solution is dried on the edge of the optic.One haptic is fractured in the gusset area with suture material attached to the positioning hole of the haptic.Marks are observed on the optic.Follow up attempts were made.At this point, no further information available at this time.Broken haptic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).

• Brand Name: PMMA SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16352857
• Report Number: 1119421-2023-00279
• Device Sequence Number: 6824566
• Product Code: HQL
• UDI-Device Identifier: 00380650696588
• UDI-Public: 00380650696588
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P840060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CZ70BD
• Device Catalogue Number: CZ70BD.230
• Device Lot Number: 15343780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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
• Patient Sex: Unknown