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	Flashers (1864); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient¿s right eye in a secondary surgical procedure due to mechanical failure of the lens.The patient had decreased near vision after the iol was implanted and stated he was unable to read.The patient also complained of significant glare/starbursts around lights with new lenses that did not improve over time.Patient's most recent complaint was on (b)(6) 2021 when he returned to the doctor¿s office for discussion of iol exchange.A replacement lens of different model, dfr00v and 16.5 diopter was used.There was no incision enlargement and no vitrectomy required.The patient was reported to be doing fine.No further information was provided.Initial pre-op visual acuity: uncorrected visual acuity right eye (od): 20/30 at distance, 20/30 at near.Post-op visual acuity after original l lens implanted: uncorrected 20/80 distance, near 20/400 checked after implant on (b)(6) 2019, most recent visual acuity prior to explant for od uncorrected: 20/30 at distance, 20/100 at near.Post-op visual acuity after dfr00v lens was implanted: 8 days after surgery, 20/50 distance, 20/100 near (patient has not had further post-op evaluation).The patient had bilateral lens implants.This emdr report pertains to the event on patient¿s right eye.A separate report is being submitted for the patient¿s left eye.
Additional Manufacturer Narrative
Weight: unknown/ not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the manufacturing records for the device were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specifications.A search in complaint system revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency and the reported event cannot be confirmed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: 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 in 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: 12708913
• Report Number: 2020664-2021-07941
• Device Sequence Number: 4239702
• Product Code: POE
• UDI-Device Identifier: 05050474579040
• UDI-Public: (01)05050474579040(17)230105
• 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: 01/05/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0175
• 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: 11/18/2021; 12/30/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/29/2021; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2018
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White