MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CCA0T0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Capsular Bag Tear (2639); Zonular Dehiscence (2698)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that during intraocular lens (iol) implantation, there was temporal zonular dehiscence due to the iol moving posteriorly and compressing the temporal anterior capsular flap prior to lens reaching the central anterior capsular opening.Additional information has been requested stating the there was a tear in capsule due to the event.The implanted iol was explanted during initial procedure and the surgery was completed with a back up lens.
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
Correction information provided in e.3.And g.2.- initially reporter occupation was incorrectly selected as non healthcare professional whereas it should be nurse.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information provided in b.5.And h.6.- patient code 1845 was inadvertently not added in the previous reports submitted.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during intraocular lens (iol) implantation, there was temporal zonular dehiscence due to the iol moving posteriorly and compressing the temporal anterior capsular flap prior to lens reaching the central anterior capsular opening.The implanted iol was explanted during initial procedure by enlarging the temporal wound and the surgery was completed with a back up lens.Additional information has been requested stating the there was a tear in capsule due to the event.

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15313478
• Report Number: 9612169-2022-00427
• Device Sequence Number: 14984360
• Product Code: HQL
• UDI-Device Identifier: 00380652397308
• UDI-Public: 00380652397308
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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: 08/16/2024
• Device Model Number: CCA0T0
• Device Lot Number: 25254499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/31/2022; 11/04/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/21/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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: DUOVISC OVD.; DUOVISC VISCOELASTIC SYSTEM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown