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

Model Number	SA60AT
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during surgery the surgeon noticed a detached haptic after the intraocular lens (iol) was implanted.The damaged iol was then removed in an initial procedure.According to additional information received on 30-jul-2024, after implanting the lens into the eye, it turned out that the lens was damaged - the optics were broken.The lens was removed and new company lens was implanted in an initial procedure.There was no patient impact, just the surgery was delayed.
Additional Manufacturer Narrative
Correction provided in d.4.Additional information was provided in h.3.,h.6 and h.11.The product was not returned for analysis.The complainant states the use of company cartridge and non-company injector, which are not qualified to be used with the associated iol (intra ocular lens) model.The reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow ifu (instructions for use), as the surgeon states the use of non-qualified cartridge and injector.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Iol returned positioned correctly in the intraocular lens (iol) case.Solution is dried on the iol optic.One haptic is broken/torn and not returned, the other haptic is intact.A segment of the iol optic at the haptic gusset is missing, the edge of the remaining optic is chipped.The optic is also cracked/fractured and scratched/marked-rejectable the complainant states the use of company model cartridge and spring royale iii injector, which are not qualified to be used with the associated iol 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 ifu, as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 20108481
• Report Number: 9612169-2024-00843
• Device Sequence Number: 8572080
• Product Code: HQL
• UDI-Device Identifier: 00380652555920
• UDI-Public: (01)00380652555920(17)281230(11)240102(10)25774816
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

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.260
• Device Lot Number: 25774816
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 04/14/2025
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 11/14/2024; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; SPRING ROYALE III INJECTOR.
• Patient Sex: Unknown