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

Model Number	SA60AT
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: 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 facility representative reported that during a cataract surgery with an intraocular lens (iol) implantation, a "line in the optic zone" was observed.The iol was replaced in the same procedure with no reported harm to the patient.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the iol.Additional observations were as follows: iol returned positioned correctly in the iol case.Solution is dried on the iol.Marks are observed over the optic.The optic edge is nicked/chipped.The product investigation could not identify a root cause for the reported complaint ¿a line in the optic zone¿.The product was subject to handling and the reported damage was highlighted post implantation.The returned iol shows evidence of handling by the customer due to the presence of solution dried on the returned iol.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.The reported complaint is lacking in relevant information such as associated products used to complete a thorough investigation.Based on these investigation findings, we are unable to verify if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.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
• MDR Report Key: 11476887
• Report Number: 9612169-2021-00054
• Device Sequence Number: 3281022
• Product Code: HQL
• UDI-Device Identifier: 00380652555913
• UDI-Public: 00380652555913
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.255
• Device Lot Number: 21282857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1