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

Model Number	ZXR00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).Device evaluation: the device was not returned to the manufacturer as the lens remains implanted.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Initially, it was reported that the patient was not happy with distant vision.After the implantation of the symfony lenses, patient experienced halos and starburst on the sides, in all lights.Additional information indicated that the physician is evaluating patient symptoms and hopes that the solution will simply be a lasik touch up for the minor refractive error on both eyes.Further information reported that no explant at this time, patient is wearing corrective lenses for fine tuning distance vision.However, patient will probably need lasik touch up.The physician reported that patient was at 3 weeks post op on (b)(6) 2016, and feels better with darker glasses.Patient does not have any corneal changes or dry eyes.Patient has -0.75 diopter of residual astigmatism in both eyes.Furthermore, the physician indicated that the lens has a cloudy central area.Doctor was questioning if the lathe lines that he saw at the central, 0.75mm of the symfony lens could cause myopia.Reportedly, at this time, patient did not want any intervention performed and is content with wearing glasses.This report will capture zxr00 lens implanted on the left eye.A separate mdr report will be filed for the lens implanted on the right eye.
Additional Manufacturer Narrative
Additional information: photos of the lens implanted were reviewed.Better quality, slit beam photos need to be obtained to evaluate any opacity and location.Based upon the photos received, it was not possible to define a product deficiency as it is difficult to make anything of the photos as photo quality was not optimum.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
• MDR Report Key: 6302655
• Report Number: 9614546-2017-00079
• Device Sequence Number: 19235084
• Product Code: POE
• UDI-Device Identifier: 05050474579248
• UDI-Public: (01)05050474579248(17)210921
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/21/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 02/24/2017
• 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: Other