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

Model Number	ZCU150
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight: unknown, information not provided.Ethnicity and race: unknown, information not provided.D6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted, give date: not applicable, as there is no indication that the lens was implanted 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the zcu150 intraocular lens had scratch.There was a patient contact and left eye was affected, however they does not know if it was inserted or does not know what part made contact.There was no use error.No medical/surgical interventions were required.No other information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 4/18/2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed scratches on the optic body.No additional defects before and after cleaning were observed.Conclusion: the complaint issue (dc-cosmetic issues) was confirmed 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.Based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.There is no indication of a product deficiency or product malfunction could be identified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.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 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: 16753357
• Report Number: 3012236936-2023-00948
• Device Sequence Number: 8576436
• Product Code: HQL
• UDI-Device Identifier: 05050474657816
• UDI-Public: (01)05050474657816(17)270625
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/25/2023

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 Model Number: ZCU150
• Device Catalogue Number: ZCU150U210
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2022
• 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
• Patient Sex: Female