MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient was implanted bilateral implants sometime in (b)(6) 2019.But these intraocular lenses (iols) were explanted due to mechanical failure.It was learned that by mechanical failure, the customer meant that the patient had decreased near vision after implant of the lenses and he was unable to read.He also complained of significant glare with new lenses that did not improve over time.Initial pre-op visual acuity for left eye: uncorrected visual acuity left eye: 20/20 distance, 20/30 at near.Post-op visual acuity after implanting the zxr00 lens: uncorrected: 20/60 distance, 20/100 near checked on (b)(6) 2019, most recent visual acuity prior to explant was 20/50 distance, 20/50 near.Post-op visual acuity after implanting the dfr00v lens, 20.0 serial number (b)(4): 1 day post op 20/50 at distance, 20/100 near (patient has not had further post op yet).No other information was provided.This report captures event for left eye.A separate report will be submitted for event in right eye.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the initial mdr report inadvertently did not include the following information in the section b5; therefore, the information has been captured in this supplemental mdr report.Section b5: there was no patient injury such as capsular tear reported.Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed and no nonconformance report was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed one additional complaint was received for this production order.Since the complaint issues reported were unrelated, no escalation was required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: nov 30, 2021.Device evaluation: the complaint lens was received stuck to paper inside of a specimen cup.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12708872
• Report Number: 2020664-2021-07940
• Device Sequence Number: 4239701
• Product Code: POE
• UDI-Device Identifier: 05050474579101
• UDI-Public: (01)05050474579101(17)220615
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/12/2021; 12/29/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/12/2021; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White