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

Model Number	ZXR00
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
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.Explant date: if explanted, give date: not applicable, as the lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxr00 28.5 diopter intraocular lens (iol) was implanted into the left eye (os) on (b)(6) 2017.Reportedly, the doctor reported the lens as decentered in the patient's left eye.The patient refracts well and contact lenses are helping.However, it was reported that it's not ideal to wear contacts if there is another option such as repositioning the lens.Currently, the plan is to follow up with the doctor to discuss options for resolution.Furthermore, the patient's chart indicated the patient is experiencing glare, trouble reading, and straining.Post op visit, on date of service (b)(6) 2017, indicated the patient's refraction as -0.50 x +1.25 x 145 with a visual acuity of 20/20.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received reported that no secondary surgery has been done to the patient as of now, as patient is tolerating the symptoms.No additional information was provided.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.A search revealed that no similar complaints were received from this production order.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 johnson & johnson surgical vision, inc.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: 7051421
• Report Number: 9614546-2017-01145
• Device Sequence Number: 19195167
• Product Code: POE
• UDI-Device Identifier: 05050474591769
• UDI-Public: (01)05050474591769(17)220516
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2018

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: 05/16/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 01/18/2018; 02/26/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 02/14/2018; 03/23/2018
• 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: Other