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

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight: unknown as information was asked but not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.Device evaluated by mfr: the device was not returned for analysis therefore, a visual analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) haptic broke and there was contact with the patient¿s ocular dexter (right eye).Through follow-up, additional information was received confirming no unplanned incision enlargement, no serious patient injury, no unplanned suture(s), and no unplanned vitrectomy.The same procedure completed successfully using backup lens with the same model and diopter size.Patient outcome post-procedure was reported as good.No further information is available.
Additional Manufacturer Narrative
Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 07-apr-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside the original lens case inside a plastic bag, in the original folding carton.Visual inspection under magnification was performed and revealed that the lens was cut in half and had a detached haptic and had dry ophthalmic viscosurgical device (ovd) on it.The lens was cleaned and visually inspect under magnification and scratches were observed on the optic body.No additional issues were observed with the returned product.Haptic damaged, the complaint issue, could not be confirmed.However, the observed issue ¿haptic detached¿ is similar to the complaint issue ¿haptic damaged¿ and could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL 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: 13476961
• Report Number: 3012236936-2022-00312
• Device Sequence Number: 12064952
• Product Code: HQL
• UDI-Device Identifier: 05050474530676
• UDI-Public: (01)05050474530676(17)260624
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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): 06/20/2022

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: 06/24/2026
• Device Model Number: Z9002
• Device Catalogue Number: Z900200190
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White