MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	AU00T0
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A nurse reported during the preparation of the iol while removing "the blue lens lock" the cartridge opened and exposed iol.It seemed like the small clip holding the lens chamber closed was loose.The surgery was delayed for a few minutes but was completed with a back up lens without any enlarged incisions nor any sutures were needed.There was no patient harm and the patient was ok.
Additional Manufacturer Narrative
The product was returned for analysis and the reported damage was not observed.Additional observations were as follows: the device is returned loose in the carton.The lens stop and the plunger is present on the device.Viscoelastic is observed in the device.The lens bay door is closed securely - it closes and opens with no issues.The lens stop can be removed with no issues.We are unable to determine the root cause for the reported complaint "cartridge opened and exposed company lens".The device was returned with the lens bay door securely closed.No damage was observed to the returned device.The returned device shows evidence of possible handling by the customer due to the presence of solution dried in the device.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED 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: 12870066
• Report Number: 9612169-2021-00274
• Device Sequence Number: 17070829
• Product Code: HQL
• UDI-Device Identifier: 00380652394727
• UDI-Public: 00380652394727
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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 Expiration Date: 01/07/2024
• Device Model Number: AU00T0
• Device Lot Number: 25129155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; DISCOVISC.
• Patient Sex: Female