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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable as the lens remains implanted, however an explant is planned.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the physician was aiming for a -2.00 or -2.25 mono vision on patient's left eye however the implant resulted in -4.25+150 cylinder x 127.The toric intraocular lens (iol) in the right eye came out great with -0.5+0.75 x052.The patient is status post lasik in both eyes.The ora (ocular response analyzer) was used for both cases.The physician is planning on doing a toric multifocal exchange in the left eye (os) due to patient experiencing blurry and hazy vision and has issues with her distance and near vision and her reading is affected.Secondary issues noted as dry eye syndrome, ocular histoplasmosis and ocular migraine.
Additional Manufacturer Narrative
Additional info: in follow up, the following information was provided.The stable refraction is �-4.00 + 1.50 x 135 bcva 20/25� -2 (best corrected visual acuity).The vision is less than 20/20 suggesting dry eye is a significant problem.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 product 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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6165004
• Report Number: 9614546-2016-00671
• Device Sequence Number: 998122
• Product Code: HQL
• UDI-Device Identifier: 05050474552227
• UDI-Public: (01)05050474552227(17)190609
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: 06/09/2019
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2016
• Supplement Report FDA Received Date: 05/03/2017
• 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