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

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017 and (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zma00 21.5 diopter intraocular lens (iol) was implanted into the patient's eye.It was later explanted due to an unexpected refractive error.The replacement lens was a z9003 20.5 diopter lens.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 03/15/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The product was inspected by a qualified inspector using a microscope with a 12x magnification, it can be seen that there are scratches on the posterior side of the optic body and a haptic is missing and the optic body is being cut in.Investigation and the condition of the returned lens sample do not suggest the damage was introduced during manufacturing.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 and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received from the doctor.Doctor stated that his patient started to experience halos and glare on (b)(6) 2018.Patient visited the office again on (b)(6) 2018, and that was when the doctor explanted the iol from her right eye and replaced it with a z9003 standard lens and placed in the sulcus (back).The original iol was still in perfect condition with the exact power, ''it was spot on''.It was centered perfectly, but it was not working for the patient.The doctor removed the iol from the patient's right eye because it was the dominant eye and they were aiming for distance vision.Incision was enlarged 3mm.A suture was placed; however, no vitrectomy was needed.Patient was seen back in the office at 5 weeks post-op with a smile on her face.Vision was at 20/25.She is able to drive at night and very comfortable with the lens.The following sections have been updated: age/date of birth: (b)(6); gender/sex: female; date of event: (b)(6) 2018.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7336801
• Report Number: 9614546-2018-00247
• Device Sequence Number: 402721
• Product Code: MFK
• UDI-Device Identifier: 05050474536838
• UDI-Public: (01)05050474536838(17)200922
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 09/22/2020
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/22/2018; 04/30/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/20/2018; 05/29/2018
• 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: 73 YR