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

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3-other (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 that an intraocular lens (iol) was explanted from a patient left eye as the patient complained of halos and decreased visual acuity.A non-johnson and johnson lens of 19.5 diopter was used as a replacement.No medical or surgical interventions were required, and no patient injury reported.The patient is doing fine post explant.No further information was provided.
Additional Manufacturer Narrative
The following codes were updated upon further review of the product investigation: section h6: type of investigation: 10 - testing of actual/suspected device section h6: investigation findings: 114 - operational problem identified section h6: investigation conclusions: 4315 - cause not established.The following codes are no longer applicable: section h6: type of investigation: 4116 - incomplete device returned section h6: investigation findings: 213 - no device problem found.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: feb 5, 2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint lens reveal that it was cut in half and coated in viscoelastic residue.The lens was cleaned and further inspected, and no issues that could cause or contribute to the complaint issues were observed.The complaint issue "explant, halo vision, and sub-optimal results" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation, no malfunction or product deficiency was 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: 18598134
• Report Number: 3012236936-2024-00221
• Device Sequence Number: 9016585
• Product Code: POE
• UDI-Device Identifier: 05050474761797
• UDI-Public: (01)05050474761797(17)250419
• 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: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/29/2024

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: 04/19/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU200
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/01/2024; 03/29/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/28/2024; 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White