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

Model Number	ZCB00
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The account initially reported that there was an imperfection, debris marking on the intraocular lens (iol).Additional information received from the account indicated that deposits were noted on the lens while inserting it into the right eye (od) of a patient.The iol was removed and replaced in the same procedure.The replacement lens was of the same model and diopter.There was no cartridge tip damage and reportedly the issue was not due to use error.There was no reported patient injury reported.No incision enlargement, vitrectomy, and/or sutures were required.The patient is doing well post-operation.No additional information was provided.
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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 and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 10/3/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of the original lens case.Visual inspection under magnification revealed that the complaint lens was received cut in half and coated in viscoelastic residue.The lens was cleaned and, no issues could be identified with the lens.Based on the return condition of the lens, no further product evaluation could be identified.Conclusion: as a result of the investigation there is no indication of a product deficiency or product malfunction.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: 15424984
• Report Number: 3012236936-2022-02365
• Device Sequence Number: 7502082
• Product Code: HQL
• UDI-Device Identifier: 05050474531727
• UDI-Public: (01)05050474531727(17)260610
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/26/2022

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: 06/10/2026
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White