MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT9
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
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 health care professional reported that during implantation of an intraocular lens (iol) the lens was defective.Additional information was requested and received, the lens had damaged optics, explanted on the same day and performed anterior vitrectomy and implanted with other lens.
Additional Manufacturer Narrative
Additional information was provided in d.9, h.3, h.6, and h.10.Correction information was provided in h.6 (during initial report 4582 was submitted in error) the lens was returned for evaluation.The returned lens matches the provided photo(s).Solution is dried on the lens.The distal tip of a haptic is broken.A deep gouge is observed on the optic of the anterior side.Cracks are observed in the center of the optic.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge and unspecified handpiece.The file also indicates the use of a non-qualified viscoelastic.Lens damage was observed.The root cause for the reported complaint may be related to a failure to follow the ifu.The viscoelastic indicated is not qualified for the lens/delivery system combination used.The ifu instructs that an qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12223904
• Report Number: 1119421-2021-01448
• Device Sequence Number: 19927937
• Product Code: MJP
• UDI-Device Identifier: 00380652279130
• UDI-Public: 00380652279130
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 07/13/2025
• Device Model Number: SN6AT9
• Device Catalogue Number: SN6AT9.220
• Device Lot Number: 15082942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: BA
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC; ANOTHER COMPANY LENS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; AMVISC; ANOTHER COMPANY LENS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Outcome Attributed to Adverse Event: Required Intervention