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

Model Number	SA60AT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that, the lens found to be faulty.Additional information received and stated that during phacoemulsification with intraocular implant procedure lens loaded unto cartridge, advanced but was not engaging with the company injector.Reloaded both by surgeon and scrub nurse, lens engaged but got stuck at the tip of the cartridge whilst implanting in the eye.The procedure was completed with back-up lens.There was no patient harm.
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that, the lens found to be faulty.Additional information received and stated that during phacoemulsification with intraocular implant procedure lens loaded unto cartridge, advanced but was not engaging with the company injector.Reloaded both by surgeon and scrub nurse, lens engaged but got stuck at the tip of the cartridge whilst implanting in the eye.The procedure was completed with back-up lens.There was no patient harm.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint could not be observed.No cartridge was returned.Additional observations were as follows: iol returned pressed down into well area of iol case base.A significant amount of solution is dried on both surfaces of the optic and haptics.One haptic is bent and pinched, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable with loose fibers & particulate.The optic and one haptic met specifications when dimensionally measured for edge thickness and plan view, the other hapic could not be measured due to the condition it was received.The product investigation could not identify the root cause for the reported complaint "stuck at the tip of the cartridge" as only the iol was returned for evaluation.No cartridge was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.The dimensions of the lens (optic and one haptic) were tested using an approved template and results show the lens dimensions to be within specification.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: 2022-03814.

• 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: 13534977
• Report Number: 9612169-2022-00070
• Device Sequence Number: 14471344
• Product Code: HQL
• UDI-Device Identifier: 00380650141279
• UDI-Public: 00380650141279
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2026
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.310
• Device Lot Number: 25229900
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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 IOL CARTRIDGE.
• Patient Sex: Unknown