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

Model Number	DXR00V
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: sections a-4 patient weight and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was removed and replaced during the same procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the same procedure, therefore not explanted.Section h3-81: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation 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 after implantation, the doctor noticed a haptic was missing on the dxr00v model intraocular lens (iol).The iol was removed from the patient¿s ocular dexter (right eye) and the same procedure was completed using back-up lens with the same model and diopter size, dxr00v 19.0 diopter iol.There was no incision enlargement, no medical attention was required, no sutures, and no vitrectomy.Patient's daily activities were not significantly affected.Patient outcome post-procedure was reported as fully recovered.No further information is available.
Additional Manufacturer Narrative
Upon further review.It was noted, that section g-3 date received by manufacturer, 02-jun-2023, reported in the initial mdr was incorrect.The information was updated from 02-jun-2023 to 01-jun-2023.Therefore, this supplemental filing is to correct the date received by manufacturer, that was incorrectly reported.The following fields were updated accordingly: section g-3 date received by manufacturer: 01-jun-2023.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: additional information was received with suspect device return, indicating event date was 31-may-2023 (01-jun-2023 was initially reported.The following has been updated accordingly: section b-3: date of event: 31-may-2023.Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 29-jun-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of a bag.The original handpiece was received as well.Visual inspection under magnification revealed that the complaint lens was received cut in half and with a detached haptic (missing).The lens was cleaned and, no further issues were observed.The remaining haptic was measured and determined to be within specification.Visual inspection under magnification revealed that the handpiece was received with the plunger rod fully advanced.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute the complaint issue could be identified.The missing haptic could not be found in the handpiece.Complaint issue of dc-haptic detached was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other issues observed during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17113606
• Report Number: 3012236936-2023-01455
• Device Sequence Number: 6468652
• Product Code: POE
• UDI-Device Identifier: 05050474761773
• UDI-Public: (01)05050474761773(17)250423
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 07/24/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/24/2023; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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
• Patient Sex: Female