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 Codes	Failure to Advance (2524); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been one other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, tip of the injector was already in the patient eye as the plunger passed the lens and leaving the lens in the injector.Replacement product was introduced and procedure was completed on same day.There was no harm to patient.Additional information was requested.
Additional Manufacturer Narrative
Correction information provided in h.6.(product problem code updated).The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.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
• MDR Report Key: 11813767
• Report Number: 9612169-2021-00119
• Device Sequence Number: 3910655
• Product Code: HQL
• UDI-Device Identifier: 00380652394734
• UDI-Public: 00380652394734
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 08/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 21252856
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE