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

Model Number SA6AT6

Device Problem Malposition of Device (2616)

Patient Problems Blurred Vision (2137); Visual Disturbances (2140)

Event Type  Injury  

Event Description

A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurring left eye, impedes driving.The clinical reason for explant was lens off target.The iol was exchanged for another lens model 3 months following the initial implant procedure.Additional information has been requested there are two medical device reports associated with this patient.This report is associated with the 2 of 2 files.Follow up information received as this is not a bilateral file - but an explanted lens for replacement iol used in case (b)(4).

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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received and stated that the iol shifted, at which point the surgeon felt like a capsular tension ring (ctr) would help stabilize the iol.However, while attempting to place the ctr the patient was found to have quite a bit of scarring/adhesions to the bag and it was felt that trying to place a ctr was too risky; at that point the surgeon opted to explant the iol and implant a standard iol with option for lasik to correct his astigmatism at a later date.Currently the patient is doing well and has had no adverse complications.There are two medical device reports associated with this patient.This report is associated with the 2 of 2 files.

Manufacturer Narrative

Correction information provided in d.10.Additional information provided in h.3.,h.6.And h.10.The account indicated the use of a qualified associated cartridge and handpiece.The viscoelastic indicated is not qualified for use with this lens with any qualified lens/cartridge/handpiece combinations.The product investigation could not identify a root cause for the reported complaint.The explanted lens was not returned.Information in the file indicated that the replacement lens for the company lens 9.0 diopter was a non-company +11.00 diopter lens.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15722358
• MDR Text Key: 303031978
• Report Number: 1119421-2022-02340
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652360838
• UDI-Public: 00380652360838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: SA6AT6
• Device Lot Number: 12639831
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 11/02/2022; 12/07/2022
• Supplement Dates FDA Received: 12/01/2022; 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LI61AO, +11.00,4861304050; MONARCH II CARTRIDGE B; MONARCH III INJECTOR; NUVISC
• Patient Outcome(s): Required Intervention
• Patient Sex: Male