MAUDE Adverse Event Report: NOT APPLICABLE IOL WEB-BASED CALCULATOR, ACRYSOF IQ TORIC SINGLE-PIECE; LENS, INTRAOCULAR, TORIC OPTICS

Model Number VER. 3.3.0

Device Problem Application Program Problem: Power Calculation Error (1473)

Patient Problem Blurred Vision (2137)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was not 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.The manufacturer internal reference number is: (b)(4).

Event Description

A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision and a clinical reason for explant of mechanical complication.The iol was exchanged in a secondary procedure following the initial procedure.Additional information has been requested and provided that astigmatism by topography.Company toric calculator stated no toric lens needed (x2).Calculator post op showed needed astig.Correction.Toric contact lenses showed did need.Iol toric exchange did correct problem.Contact lens was used only as diagnostic tool.

Manufacturer Narrative

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

• Brand Name: IOL WEB-BASED CALCULATOR, ACRYSOF IQ TORIC SINGLE-PIECE
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): NOT APPLICABLE; not applicable; not applicable TX 76134
• Manufacturer (Section G): NOT APPLICABLE; not applicable; not applicable TX 76134
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14713201
• MDR Text Key: 295154717
• Report Number: 1610287-2022-00044
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VER. 3.3.0
• Device Catalogue Number: ALCUNK00005
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ VIVITY EXTENDED.; ACRYSOF IQ VIVITY TORIC EXTENDED.; PROVISC.
• Patient Age: 54 YR
• Patient Sex: Female