MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during intraocular lens (iol) implantation surgery, it was noted that both the iols had scratches on them.Both lenses were removed in an initial procedure.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens has been cut in half.Small scratches can be seen on one portion of the optic.Lens damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company's release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Conflicting information was given about patient contact.The latest information was that there was no patient contact.Follow up attempts were made.At this point, no further information available at this time.Associated products were not provided.It is unknown if qualified products were used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company foldable intraocular lenses (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The instructions for use (ifu) instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a reportable malfunction.Hence, no report will be submitted further.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received.The lenses were not removed and replaced in an initial procedure, as reporter claimed that neither lens touched the patient.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17396194
• Report Number: 1119421-2023-01334
• Device Sequence Number: 5921880
• Product Code: HQL
• UDI-Device Identifier: 00380650141309
• UDI-Public: 00380650141309
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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.340
• Device Lot Number: 15583904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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
• Patient Sex: Unknown