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).

Manufacturer Narrative

This is a 54-year-old female patient who was scheduled to have cataract surgery performed on the right eye (od).The web based iol calculation tool was used to suggest the initial iol implanted on (b)(6) 2022.The iol exchange was eventually performed on (b)(6) 2022.The surgeon observed blurry visual acuity (va) with the 1-day post-operative examination.The surgeon attributed this issue to the iol implantation suggestions by the "web-based intraocular lens (iol) calculation" tool that was used.The following observations were listed: 1.The patients astigmatism was visible (via topography), 2.The toric calculator indicated there was "no toric iol needed" (twice), 3.In the calculator post-op examination, it showed the patient did need the astigmatism correction, and then 4.The surgeon used toric contact lenses (as a diagnostic tool to confirm the issue).The surgeon states that the iol toric exchange resolved the issue.There was no confirmation of what information was entered into the calculator.The following information are the parameters provided for review: the web based iol calculation formula(s) was used contained the barrett calculation methods.The target refraction: plano.This patient was not a contact lens (cl) wearer.Additional medical and ocular histories were not provided for review.Pre-op measurements before initial implantation: uncorrected visual acuity (ucva): 20/800, best corrected visual acuity (bcva): 20/800, and manifest refraction (mrx): (-3.75 + 0.75 x 090) post-op measurements after initial implantation: ucva: 20/60 +2, bcva: 20/50, and mrx: (-3.50 + 0.75 x 075) the company's online toric iol calculator is an internet application that utilizes patient specific biometry and keratometry data with iol formulas (e.G., barrett toric and holladay toric) to assist with astigmatism management calculations and creation of cataract surgical plans.The toric iol web-based calculators use the mathematical average eye method to assist the user in creating a cataract surgery plan for adult patients with corneal astigmatism.In the instructions for use (ifu) the following information is listed: caution: error or caution messages will highlight input data that are not within normal or required ranges with a yellow or red text, respectively.Please ensure that the input data is correct.Notes: 1.Company does not receive or retain any patient information from company¿s online toric iol calculator.2.The axial length is generally between 20 mm and 27 mm.Measurements outside this range should be re-verified.3.The anterior chamber depth is generally between 2.00 mm and 4.00 mm.Measurements outside this range should be re-verified.4.Calculation details are provided in "diopter (d)" regardless of the "k notation" selection.5.K measurements are generally between 30.00 d and 55.00 d (11.25 mm and 6.13 mm when k-index is 1.3375).Measurements outside this range are not accepted.6.Meridian measurements must be an integer between 0 and 180 degrees.7.The incision location must be an integer between 0 degrees and 359 degrees.Product evaluation: there is no associated batch/lot/serial number with the online toric iol calculator, therefore no similar complaints review was performed.Service history was reviewed for the system.No service record relevant to the complaint reported event was found.The iol calculator is a web-based application and therefore, review of an associated device history record is not required.Based on the information obtained, the root cause of the reported event is inconclusive.Based on the information obtained, the root cause of the reported event is inconclusive.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,Followup
• Report Date: 08/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 05/04/2023; 08/02/2024
• Supplement Dates FDA Received: 05/26/2023; 08/30/2024
• 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