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

Model Number	ZXR00
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient info: unknown/ not provided.Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2021 and (b)(6) 2021.Other: the device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a customer is looking for some guidance on what might be causing the post-op (operative) miss in an "off-label" case.The patient had unexpected residual refractive error after a bilateral symfony implantation.The doctor also patient also reported the patient has dysphotopsia, therefore, the intraocular lens (iol) was removed from the left eye.The lens was discarded.The lens was replaced with eyhance iol, serial number is unknown.Prior to refractive lens exchange (rle): right eye (od) +1.50 ds; left eye (os) +1.25-0.50x045.Post rle: od -1.50-0.25x135.No other information was provided.This report captures the suspect product for the left eye.A separate report will be submitted for the right eye suspect product.
Additional Manufacturer Narrative
Additional information: new information received that the patient main complaint was seeing halos all the time.Suspect lens was replaced with a dib00, 22.5d, sn(b)(6).Patient date of birth (b)(6) 1969.No other information was provided.The following sections are updated: section a2: date of birth: (b)(6) , 1969.Section h6: health effect: clinical code: 2227.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: jan.29, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptic and that the lens was received cut in half (one half missing), 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.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 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: 12360125
• Report Number: 2020664-2021-07090
• Device Sequence Number: 19788848
• Product Code: POE
• UDI-Device Identifier: 05050474579156
• UDI-Public: (01)05050474579156(17)230724
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/11/2022

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: 07/24/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2022
• 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: 07/28/2021
• Supplement Date Received by Manufacturer: 12/23/2021; 03/08/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 01/05/2022; 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2018
• 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 Sex: Male