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

Model Number	DIU225
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an eyhance toric ii intraocular lens (iol) prior to actual insertion appeared scratched in two separate areas.This was not believed to have occurred during advancing or handling.This iol is pre-loaded, so no cartridge was used, and no injector handpiece was necessary.No damage to the cartridge tip.It was stated that ovd was used.And that ovd was allowed to acclimatize fully to operating room temperature.No delays in the surgery before an attempt was made to advance the lens it was noted that the scratches were too small to see during loading, and not found until lens was viewed under the microscope.There was no patient contact.Another johnson and johnson iol with the same model and diopter was implanted.No other information was provided.
Additional Manufacturer Narrative
Section a2, a3, a4, a5: not applicable because no patient contact.Section d6a: if implanted, give date: not applicable, as no indication that lens was implanted.Section d6b: if explanted, give date: not applicable, as no indication that lens was implanted, hence not explanted.Section h3-other (81): 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: it was noted that per new information received that event occurred during insertion and not prior to actual insertion as reported in the initial report submitted.This supplemental report is being submitted to correct this.Additional information.New information received that doctor is dr.Gary chung, email address (b)(4).Also, or team that day was not able to salvage this lens for return, so customer will not be able to ship it back for evaluation.Suspect iol was probably cut into smaller pieces in order to remove it from the patient's eye once they discovered it was scratched, and those pieces were not able to be saved.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 18302868
• Report Number: 3012236936-2023-03151
• Device Sequence Number: 16950281
• Product Code: MJP
• UDI-Device Identifier: 05050474747111
• UDI-Public: (01)05050474747111(17)241109
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 11/09/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U190
• Was Device Available for Evaluation?: No
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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: Unknown