MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Therapeutic Effects, Unexpected (2099)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

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 has been one other complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmic surgeon reported that following an uneventful intraocular lens (iol) implant procedure, the patient's vision had not improved.At the 1 week post operative visit, striations were noted on the lens.The iol was exchanged for a different lens model 10 days following the initial implant procedure.The patient was doing well following the lens exchange.

Manufacturer Narrative

Product evaluation: the loading device was not returned.The lot number was provided.The lens was returned cut into two pieces.One haptic was broken-gusset area.Both optic portions have parallel cracks near the edge in the shape of forceps.There are two chipped areas on the optic edge of the larger portion near the "forcep" marks.No "striations" are observed.Exact focal length/resolution measurements could not be obtained due to the optic damage.However, the lens is within the 19.5 diopter range.Product history records were reviewed and documentation indicated the product met release criteria.Root cause: the root cause for the reported issues could not be determined.Exact focal length/resolution measurements could not be obtained due to the optic damage.However, the lens is within the 19.5 diopter range.The reported "striations" were not observed.Damage was observed near the optic edge, which appeared to have been caused during the lens removal.During the manufacturing process, each lens is subjected to a 100% assessment of the power and optical resolution in order to determine acceptability per the lens model and diopter.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10266818
• MDR Text Key: 198872644
• Report Number: 1119421-2020-00967
• Device Sequence Number: 1
• Product Code: KYB
• 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
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: ACU0T0
• Device Lot Number: 12614549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention