MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; MULTIFOCAL IOLS

Model Number	ZMA00
Medical Device Problem Codes	Bent (1059); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 a zma00 19.0 diopter lens was implanted in the patient's left eye (os) on (b)(6) 2018.Post-operatively, on (b)(6) 2018, a lens repositioning procedure was performed, but upon trying to reposition the lens, the doctor noticed that the haptic of the lens had a crimp in it.Therefore, the lens was explanted from the operative eye and the replacement lens was the same model and diopter.There was no patient harm and the patient is doing fine post-operatively.There was no incision enlargement or vitrectomy performed.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 06/26/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The sample was inspected by a qualified final inspection operator using 12x magnification.It can be seen, that the lens was cut.Probably to make explant possible.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
In review of the file, it was noted that device code for ''dislocation'' was not provided in any of the previous mdr''s.The device code was updated accordingly.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: in review, an emdr correction is required, as the initial emdr incorrectly reported the wrong serial number, manufacturing date, and expiration date.The correct serial number is (b)(4), the correct manufacturing date is 08/04/2017, and the correct expiration date is 08/04/2022.Expiration date: 08/04/2022.Serial number: 8303991709.Device manufacture date: 08/04/2017.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7577292
• Report Number: 9614546-2018-00545
• Device Sequence Number: 1979920
• Product Code: MFK
• UDI-Device Identifier: 05050474536784
• UDI-Public: (01)05050474536784(17)181012
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/04/2022
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 08/28/2018; 09/13/2018; 11/14/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 09/04/2018; 09/21/2018; 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005