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

Model Number	SN6AT5
Medical Device Problem Code	Optical Discoloration (2999)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An ophthalmic surgeon reported that following an intraocular lens (iol) implant procedure, lens has recently turned dark yellow 6 years post operation.Additional information was requested and received that the iol was exchanged in a secondary procedure following the initial procedure due to turning yellow.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was not observed.Intraocular lens (iol) returned in pieces in a zip lock bag.Solution is dried on both surfaces of the optic.Both haptics are broken/torn and not returned.The optic is torn/split-cut dividing the iol in two(2) and scratched/marked rejectable.The iol colour appears natural, which is consistent with model company lens.The product investigation could not identify a root cause as the reported complaint was not observed.The iol colour appears natural, which is consistent with model company lens.The product was subject to handling and the reported damage was highlighted post implantation.The returned iol shows evidence of handling by the customer due to the presence of solution dried on both surfaces of the returned segments.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.There have been no other complaints for this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that yellowed color was not glistening.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14985632
• Report Number: 9612169-2022-00327
• Device Sequence Number: 19276955
• Product Code: MJP
• UDI-Device Identifier: 00380652250887
• UDI-Public: 00380652250887
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 06/30/2020
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.145
• Device Lot Number: 21136945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown