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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Blurred Vision (2137); Halo (2227)
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.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt150 19.5 diopter intraocular lens (iol) was implanted in the patient's right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2017, due to a refractive surprise that included patient complaints of blurry vision, halos, itching of the operative eye, and a post-operative vision of 20/100.There was no incision enlargement, vitrectomy, or sutures used.The replacement lens was an aab00 18.0 diopter lens.Reportedly, the patient may have had an allergic reaction to the lens.It was reported that the patient is very happy with new lens.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 3/15/2018.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection with the unaided eye shows that the product is damaged, most probably to make the explant possible.Visual inspection using a microscope shows that the product is dirty and there is a scratch on the anterior side of the optic body.Investigation of the return sample and the condition of the return sample do not suggest that the scratch/damage was introduced during manufacturing.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7183563
• Report Number: 9614546-2018-00050
• Device Sequence Number: 16178969
• Product Code: POE
• UDI-Device Identifier: 05050474605190
• UDI-Public: (01)05050474605190(17)220522
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 05/22/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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