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

Model Number SN60WF

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Blurred Vision (2137)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: 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.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A customer reported following the implant of an intraocular lens (iol), the patient experienced foggy vision.The lens was not visualized (in the bag), and therefore a secondary exchange took place.Additional information was requested.

Manufacturer Narrative

The lens was returned wrapped in white material.Solution was dried on the lens.The optic has multiple light scratches.The lens was cleaned with lphse for further evaluation.A dimensional inspection (plan view) of the lens was conducted.The lens was within the specification per the approved template.An assessment of the power and optical resolution was conducted with the returned lens.The optical resolution is acceptable.The focal length reading was in specification for a 19.5 diopter.All product and batch history records are quality reviewed prior to product release.Associated product information was not provided.It is unknown if a qualified combination of products were used.The product investigation could not identify a root cause for the complaint.Information provided indicated that the lens was not in the bag and no iol was visualized.The root cause of this reported dislocation cannot be determined.A dimensional inspection (plan view) of the lens was conducted.The lens was within the specification per the approved template.The assessment of the returned lens' power and optical resolution indicated that the lens met specifications for a sn60wf 19.5 diopter lens model.The replacement lens of the sn60wf 19.5 diopter lens was a pmma lens model mta4u0 16.0 diopter.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: 9806938
• MDR Text Key: 182612373
• Report Number: 1119421-2020-00407
• 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: 04/24/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.195
• Device Lot Number: 12744053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 04/12/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR