MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.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 surgeon reported that during a cataract extraction with intraocular lens (iol) implant procedure, the removal of the cataract was completed uneventfully.However, when it came time to inject the lens into the bag, the haptic was amputated off the optic.They do not know the reason for this, but it could have been due to a misloaded lens or due to the fact that the iol was sitting in the cartridge for a long period of time.The tech is an experienced one and insisted that she loaded the lens correctly.The iol was slightly decentered at the end of the case and she elected to observe as the patient is monocular and this is his only good eye.However, post op day 1, his lens was further decentered.The patient is doing well now after requiring a second surgery by a retinal specialist to remove the defective lens and replace it.Additional information of patient identifiers, associated products, and relevant test data was provided.Information that the surgical tech reported that the iol loaded without issue, but when the surgeon took the loaded lens injector, she stated it was hard to push, so she asked the surgical tech for forceps.The surgeon used the forceps to help the iol out of the lens injector.The surgeon then realized there was an issue with one of the haptics but continued implanting the iol.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• 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: 11685533
• Report Number: 9612169-2021-00093
• Device Sequence Number: 11545221
• Product Code: HQL
• UDI-Device Identifier: 00380655093177
• UDI-Public: 00380655093177
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 21187439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/19/2021
• 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: UNSPECIFIED CARTRIDGE; UNSPECIFIED FORCEPS; UNSPECIFIED HANDPIECE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR