MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; MULTIFOCAL IOLS

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	10/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: (b)(6) 2016.Implant date: if implanted, give date: unknown/ not provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zma00 intraocular lens (iol) was explanted due to patient vision not being great.It was reported that the patient was also experiencing glares.No further information was provided.
Additional Manufacturer Narrative
Additional info: device available for evaluation: yes.Returned to manufacturer on: 01/13/2017.Device returned to manufacturer: yes.Device evaluation: the intraocular lens was returned to the manufacturing site for investigation.The lens was inspected using 12x magnification.It can be seen that there is a crack in the haptic.Investigation of the return sample and the condition of the return sample do not suggest the crack was introduced during manufacturing.The customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The product was manufactured according to specification.A search of complaints revealed that no similar complaints were received for this production order number.Labeling evaluation: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling the lenses.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information was received from the surgery site.The implant date for the lens was (b)(6) 2016, the explant date was (b)(6) 2016.The lens was implanted in the patient's right eye.An incision enlargement, vitrectomy, and suture were required.There was no patient injury post op and the patient was reported as having good vision following explant.The lens was replaced with a non amo lens.No further information was provided.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6155500
• Report Number: 9614546-2016-00662
• Device Sequence Number: 19083461
• Product Code: MFK
• UDI-Device Identifier: 05050474536807
• UDI-Public: (01)05050474536807(17)190120
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2017

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: 01/20/2019
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 03/08/2017; 03/28/2017
• 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: 77 YR