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

Model Number	ZCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, weight, and ethnicity: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Email address: unknown/not provided, as information was asked but it was not provided.Telephone number: (b)(6).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) optic had a carving described as a sickle in the center.The surgery was completed but the patient was not satisfied with their vision.The surgeon explanted the iol and replaced with another lens.The iol exchange surgery went well with visual improvement results as expected.The patient has fully recovered.There was no delay in treatment or other interventions reported.The iol is not returning for evaluation.No further information was provided.
Additional Manufacturer Narrative
Additional information section d9: device available for evaluation: yes.Date returned to manufacturer: jan 11, 2023.Section h3: device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.A ring was identified in the center of the suspect intraocular lens (iol).Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, a ring in the center of the iol could be identified.A failure investigation was completed, and the investigation findings concluded that the device did not meet specifications and the failure was attributed to operator error.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.

• 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: 16142009
• Report Number: 3012236936-2023-00032
• Device Sequence Number: 6717548
• Product Code: HQL
• UDI-Device Identifier: 05050474531727
• UDI-Public: (01)05050474531727(17)261101
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000205
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown