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

Model Number SN6AT9

Device Problem Defective Component (2292)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  Injury  

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 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.

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
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12223904
• MDR Text Key: 263361441
• Report Number: 1119421-2021-01448
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652279130
• UDI-Public: 00380652279130
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: BA
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention