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

Model Number	SN60AT
Medical Device Problem Codes	Inaccurate Delivery (2339); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure the iol got stuck in incision site and unfortunately damaged during extraction from eye.Procedure was completed with new lens.Additional information has requested and received.
Additional Manufacturer Narrative
Correction information provided in h.6.(previously reported device codes 2339 submitted in error).The product was returned for analysis.Iol returned pressed against one(1) post of the lens case base.Solution is dried on both surfaces of the optic and haptics.One haptic is adhered to the optic surface in a folded position.Both haptics are intact.The optic is scratched/marked-rejectable.The iol met specifications when dimensionally measured for edge thickness and plan view.The complainant states the use of a non qualified combination: injector, cartridge, viscoelastic.The root cause for the reported complaint could not be determined.It was reported that the iol was stuck in the incision and damaged upon the iol removal.The use of non-qualified combinations may result in delivery issues and/or damage.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: 12227918
• Report Number: 9612169-2021-00156
• Device Sequence Number: 3444533
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 07/31/2022
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.300
• Device Lot Number: 21199704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/28/2021
• 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 DELIVERY SYSTEM; MONARCH III CARTRIDGE D; Z-HYALIN; MONARCH DELIVERY SYSTEM; MONARCH III CARTRIDGE D; Z-HYALIN