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

Model Number SN60WF

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

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.(b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, the lens was unable to fully unfold after the lens was delivered into the patient's eye.The procedure was completed the same day and the sample is available.

Manufacturer Narrative

Product evaluation: the product was returned for analysis and the reported complaint was not observed.The iol was damaged and this damage was not mentioned by the customer.Based on the results from the product, batch and sterilisation history record, the products met release criteria.Additional observations were as follows: iol returned pressed down into well area of iol case base, resulting in deformation of the iol.A significant amount of solution is dried on both surfaces of the optic and haptics.Both haptics are adhered to the optic surface in a folded position with solution.The optic is scratched/marked-rejectable.Unable to conduct fold and dimensional testing due to condition of returned sample.No cartridge returned.Root cause: the product investigation could not identify a root cause for the complaint.Optic damage was observed.A fold and dimensional test could not be conducted due to the condition of returned sample.The returned iol shows evidence of possible handling by the customer due to the presence of solution and how it was returned pressed down into well area of iol case base.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed optic damage would not meet our current release criteria.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 9533726
• MDR Text Key: 177943987
• Report Number: 9612169-2019-00429
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.220
• Device Lot Number: 21193134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES; MONARCH III IOL DELIVERY SYST; UNSPECIFIED DISCOVISC OVD
• Patient Age: 77 YR