MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU150
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	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a, patient information: a2, a4, a5: information unknown/asku.Section d6a, if implanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced during the same procedure.Therefore, not explanted.Section h3-other (81): the device was not returned for evaluation as it was discarded.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 - impact code: 4625 used to capture incision enlarged and 4631 captures removal and replacement.Section h6- health effect - clinical code: 4581 used to capture incision enlarged.Attempts have been made to obtain the missing information.However, it was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the preloaded johnson and johnson(jnj) intraocular lens (iol) was fully inserted into the patient¿s right eye.A scratch was noted through the center of the optic.The temporal incision was extended and the iol was removed and replaced during the same procedure.Therefore, the procedure was successfully completed with a backup lens.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17456744
• Report Number: 3012236936-2023-02020
• Device Sequence Number: 17918756
• Product Code: MJP
• UDI-Device Identifier: 05050474746510
• UDI-Public: (01)05050474746510(17)240426
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2023

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: 04/26/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U185
• 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: 07/14/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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