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

Model Number	DIB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-4 patient weight: unknown/asked information unavailable.Section d-6b date explanted: not applicable as the iol remains implanted, therefore not explanted.Section h3-81: the device was not returned for evaluation as it remains implanted in the patient's ocular sinister (left 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 will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported upon implantation of the dib00 model intraocular lens (iol), a scratch was noted on the lens possibly caused by the inserter tip.There was no incision enlargement, no serious injury, no suture(s), and no vitrectomy.Since the iol was well centered and the defect/scratch was not in the visual center, it was decided to leave the iol in place rather than to exchange it due to the patients restlessness during the procedure.Patient outcome post-procedure was reported as post-op visit one, patient was happy with the results and the artifact/scratch did not appear to effect the patient's vision.The suspect iol is not available for return as it remains implanted in the patient's ocular sinister (left eye).No further information is available.

• 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: 18222662
• Report Number: 3012236936-2023-03015
• Device Sequence Number: 6721397
• Product Code: HQL
• UDI-Device Identifier: 05050474731707
• UDI-Public: (01)05050474731707(17)260127
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/28/2023

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: 01/27/2026
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0175
• 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: 11/13/2023
• Initial Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White