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

Model Number	DCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a, if implanted, give date: not applicable as the iol was removed and replaced within the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced within the same procedure.Device evaluation: the device was not returned for evaluation as it was discarded.Therefore, a failure analysis of the complaint device cannot be completed.The manufacturing records review for this device shows that the unit was released within specification.Based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.There is no indication of a product deficiency or product malfunction.Attempts have been made to obtain the missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson(jnj) intraocular lens (iol) was inserted into the patient¿s right eye.It was noticed to be scratched after implantation.The iol was removed and replaced with another lens of the same model and diopter.The incision was not enlarged.Reportedly, the outcome did not significantly interfere with the patient's activities of daily life.The injector was returned to the distributor.The lens was not included in the returned package.The lens was discarded.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes section d9: date returned to manufacturer: may 11, 2023.Section h3: evaluated by manufacturer: yes device evaluation: the intraocular lens (iol) was not received as part of this return.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod advanced to the cartridge tip.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue.Inspection of the removed cartridge revealed a trace amount of viscoelastic residue inside of the cartridge, suggesting that an inadequate amount of ovd may have contributed to the complaint issue.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 SIMPLICITY
• 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: 16820666
• Report Number: 3012236936-2023-00839
• Device Sequence Number: 6987001
• Product Code: HQL
• UDI-Device Identifier: 05050474635937
• UDI-Public: (01)05050474635937(17)231213
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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: 12/13/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000125
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown