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

Model Number SA6AT5

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A facility representative reported a patient with explanted intraocular lens (iol) being disappointed in vision.The patient wanted to see near.Additional information was requested.

Manufacturer Narrative

Additional information provided in a.2., a.3., b.5., and b.6.The manufacturer internal reference number is: (b)(4).

Event Description

Additional clarification reports the patient was unhappy with their distance vision.

Manufacturer Narrative

Additional information provided in g.1., g.2., h.3., h.6., and h.10.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of non-qualified associated product.The product investigation could not identify a root cause for the reported complaint.Information was provided that the (3.00cyl), 19.5 diopter lens model was replaced with an (3.00cyl), 22.5 diopter lens.A iol exchange for a difference greater than two diopters, indicates the event is most likely related to a calculation error.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: 9539955
• MDR Text Key: 173536406
• Report Number: 1119421-2020-00020
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: SA6AT5
• Device Lot Number: 12713869
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 01/09/2020; 03/03/2020
• Supplement Dates FDA Received: 02/03/2020; 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT PLATINUM CARTRIDGE.; DUOVISC.; SA6AT5.225.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR