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

Model Number	ZA9003
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: unknown/ asked but not available.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.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 za9003 intraocular lens was inserted into patient's operative eye, however, had to be removed as it was torn.Another competitor lens was used as the replacement.Additional information received from the facility revealed that there was no patient injury and no other medical/surgical intervention was required.No other information was provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that "g4 -combination product" field was inadvertently left blank and not populated in the initial mdr report.The information has been corrected in this supplemental mdr report and the following field was updated accordingly: section g4: combination product: no.Additional information: section a2: date of birth: (b)(6) 1949.Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: apr 5, 2023.Section h3: device evaluated by manufacturer: yes.Section b5: additional information received indicated that the events reported with both za9003 lenses, serial numbers ((b)(6) & (b)(6)) were with the same patient, same eye (left eye).The account is not sure if the issue was due to a use error.Device evaluation: the lens was received torn in pieces and stuck in an emerald30c cartridge.The complaint folding carton, lens case, patient identification card (id card), implant notification card, and a patient sticker was received as well.Visual inspection under magnification revealed that the lens was received torn in pieces and stuck in an emerald30c cartridge.The complaint lens was not removed from the cartridge to avoid introducing additional damage unrelated to the returned condition.Based on the return condition of the lens no further evaluation could be performed on the lens.No defects were observed with the returned cartridge.The complaint issue "iol torn¿ 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 the manufacturing or design process.Historical data analysis: a search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.However, complaint issues reported are not related.Therefore, no escalations are required.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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: 16660178
• Report Number: 3012236936-2023-00789
• Device Sequence Number: 7274757
• Product Code: HQL
• UDI-Device Identifier: 05050474529168
• UDI-Public: (01)05050474529168(17)240211
• 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
• 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): 04/28/2023

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: 02/11/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030275
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2019
• 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: 74 YR
• Patient Sex: Male