MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	ZCT150
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown, as information was asked but not provided.Date of event: unknown as information was asked but not provided.Date implanted: not applicable, as the iol was removed and replaced during the same procedure.Date explanted: not applicable, as the iol was removed and replaced during the same procedure.The device was not returned for analysis therefore, a visual analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) was inserted into the patient's ocular dexter (right eye) and a scratch on the lens was identified after lens implantation.The iol was removed during the same procedure.Through follow-up, additional information was received the same procedure was completed successfully using back-up lens with the same model and diopter size.There was no unplanned vitrectomy.Patient outcome post-procedure was reported as unknown.No further information is available.
Additional Manufacturer Narrative
Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 22-apr-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the suspect iol was received stuck to the patient label.The lens was removed and found to be cut in half.Visual inspection under magnification was performed and revealed scratches and an edge chip on the lens.No further issues were identified.Complaint issue "cosmetic issues" was observed 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.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14116499
• Report Number: 3012236936-2022-00900
• Device Sequence Number: 16733206
• Product Code: MJP
• UDI-Device Identifier: 05050474552227
• UDI-Public: (01)05050474552227(17)220903
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/01/2022

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: 09/03/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U240
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2018
• 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
• Patient Age: 73 YR
• Patient Sex: Male