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	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Race/ethnicity: unknown; requested but not available.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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the rear haptic of the intraocular lens (iol) looked over curled in the package.Removed the iol from the package and replaced in package, and the haptic sprung back into place.The iol was loaded and inserted into the patient's left eye.Under the microscope it was noticed that the lens had a defect next to the trailing haptic.The lens was removed and replaced.There was no incision enlargement required and there were no adverse effects on the patient.The surgeon had to change technique.Through follow-up, it was learned that the lens had a "divot" located on the optic of the lens that did not look right.The issue was not noticed until the lens was fully inserted and the lens was looked at under a microscope.The iol was fully inserted and removed and replaced within the same procedure.Another johnson & johnson iol was implanted as replacement (same model, same diopter).The change of technique was confirmed to be that the surgeon had to cut the lens in half and remove it, which would normally not be required if there was no issue.No sutures, vitrectomy, or any other medical or surgical interventions were required.The patient has no issues post-operatively.A haptic issue could not be confirmed.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: sep 20, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed the lens was returned cut in half which is consistent with a lens that was handled during explant.An iol tear, detached haptic, and haptic damage was observed as well.Based on the return condition of the lens no further product evaluation could be performed.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.Per the definition of dc-lens damaged provided in amo-04-d024 rev.8 the complaint issue could not be confirmed.However, the observed issue dc-iol torn is similar to the complaint issue dc-lens 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: 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: 15349680
• Report Number: 3012236936-2022-02304
• Device Sequence Number: 5467350
• Product Code: HQL
• UDI-Device Identifier: 05050474529083
• UDI-Public: (01)05050474529083(17)270529
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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 Model Number: ZA9003
• Device Catalogue Number: ZA90030235
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2022
• 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: EMERALD INSERTER.
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 47 KG