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

Model Number SN60WF

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

A sample lens was not returned for analysis.The iol product history records were reviewed and documentation indicates the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A purchaser reported that approximately 4 months after an intraocular lens (iol) was implanted, it was exchanged for a different model with a different power due to residual astigmatism indicated after initial lens implanted.Additional information was requested.

Manufacturer Narrative

The lens was returned in a small piece of sponge.The lens has been cut in half through the center of the optic.The lens was cleaned with lphse.Power and resolution testing was attempted.Exact focal length/resolution measurements could not be obtained due to the optic damage.However, the lens is within the 20.0 diopter range.Qualified associated product were indicated.The root cause for the reported refractive error could not be determined.Exact focal length/resolution measurements could not be obtained due to the optic damage.However, the lens is within the 20.0 diopter range.Information was provided that the event was related to residual astigmatism.This monofocal does not correct for astigmatism.This monofocal lens was replaced with a monofocal toric lens.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: 8531501
• MDR Text Key: 142488846
• Report Number: 1119421-2019-00496
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.200
• Device Lot Number: 12614860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH D III; MONARCH III HP; PROVISC; MONARCH D III; MONARCH III HP; PROVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR