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

Model Number	DCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Several linear fibers were noted within the pre-loaded dcb00 model cartridge and were injected into the anterior chamber along with the intraocular lens (iol).The doctor was able to retrieve the fibers using a 27 gauge cannula.The following are all unknowns: daily activities significantly affected, incision enlargement, suture(s), vitrectomy, medication prescribed (outside of standard care), if medical attention was required, and patient status post procedure.The suspect iol is not available for return as it remains implanted in the patient¿s ocular dexter (right eye).No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female was the answer provided.Section a-4 patient weight: : unknown/asked information was not provided.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the device was not returned for evaluation as it remains implanted in the patient¿s ocular dexter (right eye).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 report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.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: 20688631
• Report Number: 3012236936-2024-000306
• Device Sequence Number: 9058774
• Product Code: HQL
• UDI-Device Identifier: 05050474636040
• UDI-Public: (01)05050474636040(17)260923
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: 09/23/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000180
• 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: 10/23/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White