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	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that during an intraocular lens (iol) implant surgery, the lens did not unfold properly.The lens was exchanged to complete the case.There was no patient impact.
Event or Problem Description
Additional information was received stating that the lens had partly been inside the eye.
Additional Manufacturer Narrative
Additional information provided in b.3., b.5., d.9., h.3., h.6.And h.10.The product was returned for analysis and the reported complaint could not be observed.Only device was returned.No iol returned.Additional observations were as follows: the device was returned loose in the carton.The lens stop and the plunger stop have been removed.The plunger is oriented correctly.Correct nozzle confirmed on the device.The plunger has been retracted to mid-nozzle.Viscoelastic is dried in the device.No damage or abnormalities observed.No lens returned.The product investigation could not identify the root cause for the reported complaint "lens does not unfold properly" as only the device was returned for evaluation.No iol was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.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
• MDR Report Key: 11769663
• Report Number: 9612169-2021-00103
• Device Sequence Number: 17088284
• Product Code: HQL
• UDI-Device Identifier: 00380652394697
• UDI-Public: 00380652394697
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 02/28/2023
• Device Model Number: AU00T0
• Device Lot Number: 21266566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/02/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC; PROVISC