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

Model Number	SA60AT
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that, during intraocular lens implantation surgery, the lens had resistance during movement through the cartridge and at the time of exit the lens was damaged.The lens was then removed.The injector and cartridge will be changed while implanting the new lens.Additional information was received stating that, no additional harm was caused to the patient.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the lens.The lens was returned cut in a half in lens case.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned.The optic is scratched/marched - rejectable and cracked/fractured - rejectable with loose fibers.The complainant indicates the use of different model of company cartridge and non company viscoelastic, these are not qualified for use with associated lens model.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified combination.The use of non-qualified combinations may result in delivery issues and/or damage.Based on the results from the product history record, the products met release criteria.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: 17816215
• Report Number: 9612169-2023-00675
• Device Sequence Number: 2302509
• Product Code: HQL
• UDI-Device Identifier: 00380652555883
• UDI-Public: 00380652555883
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.240
• Device Lot Number: 25557000
• 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: 09/04/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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: BIOVISC; MONARCH III CARTRIDGE D; MONARCH IOL INJECTOR
• Patient Age: 77 YR
• Patient Sex: Male