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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Visual Impairment (2138); Visual Disturbances (2140); No Code Available (3191)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was initially reported that a zxr00 16.0 diopter intraocular lens (iol) was implanted in the right eye (od) on (b)(6) 2017.There is a planned explant on (b)(6) 2017 because the patient was unhappy with the lens.Reportedly, the lens will be replaced with a zlb00 16.5 diopter iol.Pre-operatively, on (b)(6) 2017, the patient's visual acuity was 20/100, pin hole (ph) visual acuity was 20/40+, and refraction was -1.25 x +0.25 x 159.Post-operatively, day one, (b)(6) 2016, the patient was j10 and had a little bit of edema.In addition, visual acuity was 20/50- with no improvement using pin holes.On (b)(6) 2017, at the patient one week post-operative visit, the patient complained of unable to read up close, at distance, print is almost double and shadowy.Furthermore, the patient's uncorrected visual acuity (ucva) was 20/30 and best corrected visual acuity (bcva) was 20/20, with a refraction of +0.25 x +0.75 x 040.Later, additional information was provided.It was confirmed the lens was explanted on (b)(6) 2017 without complication, no vitrectomy or sutures were required and there was no patient injury post-op.The replacement lens was a zlb00 16.5 diopter iol.No additional information provided.
Additional Manufacturer Narrative
Through follow up additional information was provided.Explant of the lens was confirmed and was conducted on (b)(6) 2017.There was no incision enlargement, vitrectomy or sutures required at explant.No patient post-op injury reported.The explanted lens was replaced with a model zlb00.(b)(4).No additional information was provided.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was returned to the manufacturer.The product was inspected using a 12x magnification and no anomalies were found.The complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6992336
• Report Number: 9614546-2017-01045
• Device Sequence Number: 444973
• Product Code: POE
• UDI-Device Identifier: 05050474579019
• UDI-Public: (01)05050474579019(17)220505
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2018

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: 05/05/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 10/26/2017; 12/21/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 11/22/2017; 01/17/2018
• 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: 69 YR