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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon full insertion of the intraocular lens (iol) into the right eye, the haptic broke.There was no medical or surgical intervention required.It was unknown if procedure completed successfully using the same or different lens.Patient outcome is unknown.No further information is available.
Additional Manufacturer Narrative
Unknown; requested but not provided.If explanted, give date: not applicable, as there was no indication that the lens was explanted.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.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that in the initial mdr section h6, had the incorrect health effect - impact code: 2199 - "no health consequences or impact" was entered.The previous code does not apply as it is indicated that the lens was removed and replaced.Therefore, this supplemental filing is to correct report previously provided.The following fields updated: section d6a: if implanted, give date: not applicable, as it was indicated that the lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as it was indicated that the lens was removed/replaced during the same procedure.Section h6: health effect: impact code: 4631 (removal and replaced.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.Section d9: date returned to manufacturer: sep 19, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut, but the lens was not cut in half.A detached and damaged haptic could also be observed.The lens was cleaned and, lens damage as well as cosmetic issues, consistent with a lens that was crushed inside of the lens insert were observed as well.The complaint issue of dc-haptic damaged was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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: 15342232
• Report Number: 3012236936-2022-02291
• Device Sequence Number: 14711709
• Product Code: HQL
• UDI-Device Identifier: 05050474528833
• UDI-Public: (01)05050474528833(17)260114
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 10/04/2022

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: 01/14/2026
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030110
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 09/25/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/16/2022; 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• 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: Male