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

Model Number	SN60AT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.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 an intraocular (iol) implant was defective.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating the haptic was defective during a procedure.The surgeon used a new lens to complete the case.
Additional Manufacturer Narrative
Correction information has been provided in d10 (concomitant products were not mentioned in the previous report submitted) the product was returned for analysis and the reported damage was observed.Additional observations were as follows: iol returned positioned incorrectly in the iol case with gross damage.Solution is dried on both surfaces of the optic and both haptics.One haptic is broken/torn and adhered to the optic surface with solution.One haptic is adhered to the optic surface in a folded position.The optic is torn/split-cut with part of the optic missing.The optic is also scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint "defective haptic".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and haptics.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.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: 11527808
• Report Number: 9612169-2021-00060
• Device Sequence Number: 3764736
• Product Code: HQL
• UDI-Device Identifier: 00380650130501
• UDI-Public: 00380650130501
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/16/2021

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: 05/31/2024
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.300
• Device Lot Number: 21246447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 08/05/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/16/2021; 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH C CARTRIDGES; MONARCH III IOL DELIVERY SYST; UNSPECIFIED DISCOVISC OVD