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

Model Number	DXR00V
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a5: ethnicity/race: unknown, information was requested but not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.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.Section h6: health effect clinical code: 4581 (incision enlarged) attempts were made to obtain the missing information; however, the information was not available.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that once a multifocal intraocular lens (iol) was implanted in a patient¿s right eye, there was a scratch on it.There was patient contact and the lens fully inserted.The lens was removed, and a replacement lens of the same model and diopter was implanted during the same procedure.There was a 10-minute delay in procedure and the incision was enlarged, but no sutures used, and no vitrectomy performed.No additional surgical and or medical interventions were planned or required.The patient outcome was good, and no injury reported.It was indicated that a competitor¿s ophthalmic viscoelastic device (ovd) was used, but no combination of balanced salt solution (bss) and ovd and that the lubricant used was introduced into the cartridge from cartridge canopy.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: oct 16, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the device was returned for evaluation.Product evaluation was performed under magnification.The complaint device presented with the plunger rod fully advanced.The complaint device lens module was inspected and presented with no issues.The device assembly was inspected and presented with no issues.The complaint lens was received cut in half.The lens was cleaned and the edge could be observed to be damaged.The complaint issue of cosmetic issues could not be confirmed.However, the observed issue lens damaged is similar to the complaint issue cosmetic issues and could not be confirmed to be related to the manufacturing or design process.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: 17865386
• Report Number: 3012236936-2023-02490
• Device Sequence Number: 5909219
• Product Code: POE
• UDI-Device Identifier: 05050474761834
• UDI-Public: (01)05050474761834(17)250420
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 04/20/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU220
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DISCOVISCO LUBRICATION.
• Patient Age: 67 YR
• Patient Sex: Unknown
• Patient Weight: 74 KG