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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Phone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt150 intraocular lens was explanted.The patient refracted -0.62 -1.25 x160.The procedure was completed successfully using a different model, zxr00 20.0 diopter lens.No other information was provided.
Additional Manufacturer Narrative
Additional information was received, reporting implant date (b)(6) 2021.However according to patient implant card, date of implant was (b)(6) 2020 for serial number (b)(6).Patient implant card for the reported replacement lens serial number (b)(6)was implanted on (b)(6) 2021.At explant, there was no vitrectomy.The lens cut out and a new lens was implanted.The affected eye is the right eye.And the patient has history of myopic lasik in both eyes (ou).Pre-op refraction +0.75 -1.00 x110.Post-op refraction was (b)(6) weeks out: -0.62 -1.25 x160 with repeated topos a-scan.The surgeon decided not to use toric iol, but a zxr00 2/4/2021 post-op refraction +0.25 -0.50 x160.Corrected data: the following fields initially reported as unknown.Have been updated, based on the additional information.Section b7: other relevant history, including preexisting medical conditions: myopic lasik ou.Section d6a: if implanted; give date? (b)(6) 2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes; returned to manufacturer on 3/25/2021; section h3: device evaluated by manufacturer: yes.Device evaluation: 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.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.No nc/er was found as part of this manufacturing records review.Historical data analysis: the search revealed, that no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency.And the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in the initial medwatch 9614546-2021-07068, code 4582 - no clinical signs, symptoms or conditions was inadvertently populated under section h6.Therefore, the correct code 2138 - unexpected post-op refraction has been applied accordingly.No further information will be submitted under the initial medwatch 9614546-2021-07068.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11320100
• Report Number: 9614546-2021-07068
• Device Sequence Number: 3283944
• Product Code: POE
• UDI-Device Identifier: 05050474605220
• UDI-Public: (01)05050474605220(17)230701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2021

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: 07/01/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/12/2021; 04/14/2021; 06/29/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/12/2021; 05/11/2021; 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention