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

Model Number SN60WF

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Rupture (2208)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.This product malfunction was originally reported under a voluntary summary report.New information was received which prompts assessment and expedited reporting.The updated information is being sent via this 3500a report.(b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, when they went to deploy the iol it malfunctioned.Additional information was provided that the capsule ruptured during the initial procedure.

Manufacturer Narrative

Product evaluation: the lens was returned in a qualified cartridge.Viscoelastic is observed in the cartridge.The lens is advanced between the loading area and the nozzle entry area.The lens and haptic positions are acceptable for advancement.The cartridge has evidence it was placed into a handpiece.No damage observed.All product and batch history records are quality reviewed prior to product release.No problem was found with the returned iol.The lens was returned advanced in a cartridge.The lens and haptic positions were acceptable for advancement.No damage was observed.It was initially reported that the iol malfunctioned.New information on the iol card states not implanted wasted - capsule ruptured.The lens could not have contributed to a capsule rupture as it has not been delivered.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10040698
• MDR Text Key: 190474232
• Report Number: 1119421-2020-00757
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.245
• Device Lot Number: 12704227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES
• Patient Outcome(s): Other
• Patient Age: 69 YR