MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SA6AT4

Device Problems Material Too Rigid or Stiff (1544); Structural Problem (2506)

Patient Problems Failure of Implant (1924); Capsular Bag Tear (2639)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product has not returned.Product history records were reviewed and documentation indicated the product met release criteria.The root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, there was a tear in the back of the patient's capsule and the lens would not stay elevated.It was reported there was an inherent weakness in the capsule, a rough edge or something on the iol that caused the tear.It was reported the procedure had gone perfect and the capsule was intact up to that point.The iol was removed and replaced with another lens model to complete the procedure.The prognosis is good.

Manufacturer Narrative

Product evaluation: only half of the lens was returned.Viscoelastic and a small amount of blood are observed.The lens has been cut into pieces.The returned portion has an intact haptic (no roughness observed).The optic portion has a small scrape/nicked area on the posterior edge.Iol product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated.The viscoelastic indicated is not qualified with the cartridge used.Root cause: the root cause for the capsule tear could not be determined.Only part of the lens was returned.The lens had been cut into pieces.A small nick was observed on the posterior edge.Due to the condition of the returned lens portion, it could not be determined if the observed damage may have occurred during delivery or during the lens removal.No roughness was observed on the one intact haptic.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met release criteria.The viscoelastic indicated is not qualified with the cartridge used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.New information received states it is unclear if lens caused tear or if there was an inherent weakness in the capsule in that region.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10148566
• MDR Text Key: 195020914
• Report Number: 1119421-2020-00858
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: SA6AT4
• Device Lot Number: 12561469
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMVISC PLUS; MONARCH III D CARTRIDGES, 8065977763; MONARCH III IOL DELIVERY SYST, 8065977773; AMVISC PLUS; MONARCH III D CARTRIDGES, 8065977763; MONARCH III IOL DELIVERY SYST, 8065977773
• Patient Outcome(s): Other
• Patient Age: 76 YR