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

Model Number DIB00

Device Problem Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Additional information: sections a-4 patient weight and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was removed and replaced during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the initial procedure, therefore not explanted.Section h3-81: 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 report will be filed.Section h-6 health effect - impact code: 4625 - vitrectomy.Section h-6 health effect - impact code: 4631 - iol removal and replacement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported after the dib00 model intraocular lens (iol) was inserted into the patient¿s ocular sinister (left eye), a scratch was observed on the iol.The iol was removed and replaced during the same procedure and another dib00 19.0 diopter iol was implanted.There was no patient injury, no incision enlargement, and no suture(s) however, an unplanned vitrectomy was performed.Patient status post-procedure was reported as discharged.The suspect iol is not available for return as it was discarded.No further information is available.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: 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: 18956790
• MDR Text Key: 338304162
• Report Number: 3012236936-2024-00752
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731738
• UDI-Public: (01)05050474731738(17)250509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female