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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is between (b)(6) 2017.If explanted; give date: na (not applicable), the lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A report was received that a patient experienced inflammation, glares and light sensitivity on both eyes on a post ¿op exam after implantation of a tecnis symfony multifocal model zxt225 intraocular lens (iol) in both eyes.Both initial procedures were done in may 2017.The surgery center indicated the surgeries went well and the patient overall has been satisfied with vision.The uncorrected distance vision has ranged between 20/30 to 20/40 in each eye and the uncorrected near vision has ranged between j2 to j3 for each eye.The refraction has been -0.25 sphere for the right eye and left eye.The patient complaint¿s that is that the night time glare really bothers her and the patient does not like to go out at night because of that.The patient also finds certain lighting to be quite bothersome.The patient was treated with alphagan drops and pilocarpine drops.The surgery center recommended trying anti-reflective coating at night and during the day uv protective sunglasses.The patient finds nothing has helped with the glare.The patient has had longstanding post-op inflammation that has recently settled down using durezol drops.The patient¿s symptoms are interfering with daily activities as it interferes with night time driving because of the starbursts that is experienced with the lenses.The patient also states that certain night lighting conditions causes vision to be blurry.This report is for the left eye.A separate report will be filed for the right eye.
Additional Manufacturer Narrative
Device evaluation the product testing could not be performed because the product was not returned for evaluation.Device inspection could not be performed, therefore the reported complaint could not be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints 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 TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6995345
• Report Number: 9614546-2017-01054
• Device Sequence Number: 13776267
• Product Code: MFK
• UDI-Device Identifier: 05050474605916
• UDI-Public: (01)05050474605916(17)211223
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: 12/23/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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: 67 YR