MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT150
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Visual Impairment (2138); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unknown, information not provided.If explanted, give date: not applicable, as the lens remains implanted.  device evaluation: product testing could not be performed since the lens remains implanted in the patient's eye.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt150 model intraocular lens (iol) had rotated.Account's brief description of the event indicated that during the post-operative visit patient had stated that right eye (od) felt weaker than left eye (os).Visual acuity od had decreased as it was 20/30 on (b)(6) 2021 and measured at 20/40 on (b)(6) 2021, the day of the post-operative visit.The lens in the od was repositioned rotationally from 78 degrees to 18 degrees and remains implanted.There was no patient injury and no other medical/ surgical interventions were done.Patient was doing excellent when discharged.No further information available.
Additional Manufacturer Narrative
Section h6: as part of an internal review of our mdrs it was identified that the code "4582-no clinical signs, symptoms or conditions" provided in the section "h6-health effect - clinical code" of the initial report needs to be removed as it should not have been indicated in the report and instead the code "2138 - visual impairment" should have been entered.Therefore, the correction has been made in this supplemental mdr report and the following field was updated accordingly: section h6: health effect - clinical code: 2138.Note: acknowledgement 2 for this report was received on 09/22/2022.There was a delay in receiving acknowledgement 3 due to a cdrh system issue.Multiple follow-ups were conducted with the esg help desk.On 10/18/2022 esg responded requesting to resubmit the mdr.Therefore, this report is being resubmitted on 10/19/2022.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12677854
• Report Number: 2020664-2021-07827
• Device Sequence Number: 11894890
• Product Code: POE
• UDI-Device Identifier: 05050474605114
• UDI-Public: (01)05050474605114(17)240120
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U155
• Was Device Available for Evaluation?: No
• 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: 08/28/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2019
• 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