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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After the dib00 intraocular lens (iol) was fully inserted into the patient's ocular dexter (right eye) it was reported there was a large central scratch.An attempt was made to buff the iol, the scratch extended to the inner portions of the lens.The iol was cut out and a new lens with the same model and diopter size was inserted.The iol is not available for return as it was discarded.Distributor reporting form indicated incision enlargement occurred.Patient status is unknown.No further information is available.
Additional Manufacturer Narrative
Patient weight, ethnicity and race: unknown/asked information unavailable.Date implanted: not applicable, as the iol was removed and replaced during the same procedure.Date explanted: not applicable, as the iol was removed and replaced during the same procedure, therefore not explanted.Email: unknown ¿ information not provided.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 will be filed.Health effect - impact code: 4625 incision enlargement.Health effect - impact code: 4631 iol removal and replacement.Health effect - clinical code: 4581 incision enlargement.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: 16383433
• Report Number: 3012236936-2023-00364
• Device Sequence Number: 17541100
• Product Code: HQL
• UDI-Device Identifier: 05050474731844
• UDI-Public: (01)05050474731844(17)250719
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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: 07/19/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0240
• 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: 01/24/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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