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

Model Number	CZ70BD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, it was noted that the haptic kept coming off/tearing after gore-tex suture placed.The iol was exchanged with another lens during initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.Both haptics are broken in the gusset area (not returned).Product history records were reviewed and the documentation indicated the product met release criteria.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¿s 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: 17386665
• Report Number: 1119421-2023-01323
• Device Sequence Number: 6183088
• Product Code: HQL
• UDI-Device Identifier: 00380650696441
• UDI-Public: 00380650696441
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 11/30/2023
• Device Model Number: CZ70BD
• Device Catalogue Number: CZ70BD.160
• Device Lot Number: 12665063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• 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: PMMA SINGLEPIECE IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male