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

Model Number	ZCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were lines seen on the intraocular lens (iol).The lens was fully inserted into the patient's eye and then removed.The iol was replaced.There was no delay in treatment or other interventions performed.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Section e1: telephone number: (b)(6).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.H6 - medical device problem code - 3191: no code available (lathe lines).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information section d9: device available for evaluation: yes.Date returned to manufacturer: apr 26, 2023.Section h3: device returned to manufacturer: yes.Corrected data upon further review of the file, it was noted that the information provided in the initial mdr should be updated to reflect that the lens was removed and replaced in the same surgery.Therefore, this supplemental filing is to update the following fields: section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Device evaluation the product was returned to the manufacturing site for evaluation.Visual inspection of the lens under microscope revealed lathe lines in the lens which did not comply with our cosmetic acceptability conditions.The manufacturing records for the device were reviewed and no nonconformity report was found as part of this manufacturing records review.A search in complaint system revealed no other complaints have been received for this production order number.A failure investigation was completed, and the investigation findings concluded that the device did not meet specifications.The failure was attributed to operator error; the operator omitted to perform thorough visual inspection.Therefore, the complaint issue reported is confirmed as manufacturing related.A review of bounding confirmed that there were no additional units affected for similar issues.Conclusion: based on the records reviewed, the risk assessment performed and the current probability of occurrence, this issue is being evaluated as part of continuous improvement project.An awareness was conducted to all personnel involved in manufacturing the reported complaint product to reinforce the visual inspection during the process, to prevent recurrence.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: 16811988
• Report Number: 3012236936-2023-01007
• Device Sequence Number: 5435957
• Product Code: HQL
• UDI-Device Identifier: 05050474531765
• UDI-Public: (01)05050474531765(17)260118
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 01/18/2026
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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: Unknown