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

Model Number	ZCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a5: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy section d6b: explant date: not applicable, as lens was not explanted.Section e1: email address: unknown/not provided.Section e1: initial reporter telephone number:(b)(6).Section h3-other (81): the device is not returning for evaluation as to date it remains implanted and the foreign material is not returning; 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 during insertion of iol into the patient eye, a plastic-like foreign material was seen entering into the eye.The iol was fully inserted and foreign material was removed.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Date returned to manufacturer: 07 aug 2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned for evaluation, but the intraocular lens (iol) was not returned for evaluation as it remains implanted.An opened sterilization pouch was received with a dark material that was circled.The fourier-transform infrared spectroscopy (ftir) analysis of the foreign material revealed that the bulk of the plastic material was polypropylene.The ftir spectrum raw data output file was compared against the materials used during manufacturing process listed in the manufacturing site ftir library and yielded possible correlating components.Based on review, there is a possibility that the potential assignable cause could be related to device components.Although there was a high correlation results to the device components, it is not possible to determine the origin and/or where the particle came from due to the sample condition received and that polypropylene is a common material used.The manufacturing component matching with polypropylene are not black color.The issue was identified post-preparation and after the device had been utilized in the procedure.A review of complaints related to the production order (po) revealed no additional complaints, and manufacturing records confirm the device was produced and released per specifications.Conclusion: based on the complaint investigation results, the product was released within specifications.There is no indication of a product quality deficiency.However, manufacturing process cannot be ruled out as potential cause; therefor, an awareness training was conducted for all personnel involved in manufacturing the reported complaint product.Johnson & johnson surgical vision will continue to monitor these types of complaints.All pertinent information available to johnson and 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: 18044512
• Report Number: 3012236936-2023-02590
• Device Sequence Number: 18162177
• Product Code: HQL
• UDI-Device Identifier: 05050474531734
• UDI-Public: (01)05050474531734(17)270312
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: ZCB00
• Device Catalogue Number: ZCB0000210
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG