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

Model Number	ZA9003
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The surgery center reported defective lens.The lens was inserted and removed from patient's left eye during the same procedure.Incision enlargement was required.Through follow up, it was clarified that that the lens had blemish, something like a tear on it.The account does not know if the problem was due to loading error issue and/or if the lens was inspected prior to being loaded into the cartridge.No other surgical and/or medical interventions required.A replacement lens of the same model and diopter was used.A johnson & johnson cartridge was used, but the model/ lot number is unknown.The patient outcome was reported to be fine and no injury reported.The lens was discarded and will not be returned.No further information was provided.
Additional Manufacturer Narrative
A4 and a5: unknown/ asked but not available.D6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.D6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.H3-other (81): the device was not returned for evaluation as it was discarded.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.H6- health effect - clinical code 4581: no code available (incision enlarged).An attempt was made to obtain the missing information.However, the information was not available.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: 17477288
• Report Number: 3012236936-2023-02045
• Device Sequence Number: 14146625
• Product Code: HQL
• UDI-Device Identifier: 05050474529038
• UDI-Public: (01)05050474529038(17)271213
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2023

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 Model Number: ZA9003
• Device Catalogue Number: ZA90030210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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: CARTRIDGE, MODEL/LOT: UNKNOWN.
• Patient Age: 63 YR
• Patient Sex: Male