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

Model Number	SN60AT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Eye Injury (1845); Capsular Bag Tear (2639)
Date of Event	09/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.There were no other complaints reported in the lot number.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).
Event or Problem Description
A health professional reported that during an intraocular lens (iol) implant surgery, the lens remained rigid and punctured the patient anterior chamber.The surgeon had to cut out the lens and replace with another lens.Additional information has been requested and received reporting that the lens was quite rigid during implantation, there was no vitreous leak and did not required any sutures but enlarged incision.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the iol.Additional observations were as follows: iol returned in two (2) segments in the iol case.Solution is dried on both surfaces of the optic and haptics.The haptics are intact.The optic is torn/split-cut dividing the iol in two(2) and has a section missing.Unable to conduct dimensional testing due to condition of returned sample.Company lens monomer release sheet for associated monomer was reviewed, with final disposition conforming.The complainant states the use of company as viscoelastic which is not qualified to be used with the associated iol model company lens.We are unable to determine a root cause for the reported complaint.No cartridge was returned.In addition to this, the surgeon states the use of a non-qualified viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF 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
• 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: 12606129
• Report Number: 9612169-2021-00220
• Device Sequence Number: 1320645
• Product Code: HQL
• UDI-Device Identifier: 00380650130518
• UDI-Public: 00380650130518
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 01/31/2024
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.310
• Device Lot Number: 21239574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF MULTIPIECE IOL; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male