MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; MONOFOCAL IOLS

Model Number	DIB00
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: information unknown/not provided.If explanted, give date: not applicable as the device remains implanted.The intraocular lens (iol) is not returning for evaluation as the lens remains implanted; 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.Attempts have been made to obtain 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 doctor implanted an intraocular lens and after implanting the lens, he noticed a divot in the anterior surface of the lens.Once the doctor identified the divot, he used both his irrigation/aspiration (i/a) tip and 2nd instrument to see if he could remove the mark.The doctor was unable to remove it as he felt it was inside the anterior portion of the optic.The doctor was to see the patient on the next day for evaluation.Reportedly, the lens remains implanted.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information indicated that the photo provided was evaluated and it shows an implanted lens, and something can be observed on the lens surface.However, through the photo it is not possible to determine if the condition observed is related to a scratch, to inclusion or to another condition.Since there is no sample (e.G., the lens or the device) returned for further evaluation, the complaint reported cannot be confirmed by manufacturing site as related or originated during the manufacturing process.Therefore, the reported issues could not be verified, and product quality deficiency could not be determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11572943
• Report Number: 2648035-2021-07464
• Device Sequence Number: 4352045
• Product Code: HQL
• UDI-Device Identifier: 05050474731455
• UDI-Public: (01)05050474731455(17)240108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 01/08/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1