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

Model Number	DFR00V
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intraocular lens (iol) was fully inserted into patient's left eye, however, was the iol was removed during the same procedure as the lens was scratched.Another johnson & johnson lens of same model and diopter was used as the replacement.There was no patient injury.The outcome did not significantly interfere with activities of daily life.The patient's post-operative outcome was not available.No further information was provided.
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.The device was not returned for analysis.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.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: feb 18, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection of the lens under magnification revealed that the lens was received cut in half, which is consistent with a lens that was handled during removal.The lens was cleaned, and a cosmetic issue was observed on the lens.Visual inspection of the handpiece revealed that the plunger rod tip was bent, in a way that was consistent with a handpiece that had been dropped.The external assembly was inspected, and no gaps or issues were identified.The complaint issue could be confirmed; however, it may be attributed to handling during removal, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 13529384
• Report Number: 3012236936-2022-00407
• Device Sequence Number: 4227679
• Product Code: HQL
• UDI-Device Identifier: 05050474750449
• UDI-Public: (01)05050474750449(17)240329
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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: 03/29/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU085
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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: Male
• Patient Weight: 113 KG