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

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	02/12/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular 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 patient had multifocal lenses implanted bilaterally on (b)(6) 2013.She has had issues ever since.She cannot see especially at night.She had laser done to correct for astigmatism on (b)(6) 2013.She reported that it is better but still not the best and described her vision as cloudy.She had bilateral yag capsulotomy done on (b)(6) 2013, and again in the right eye in 2016 to treat significant posterior capsule opacification (pco).The patient mentioned that she is worried about posterior chamber weakening.The last surgeon she went to see (dr.Chung) suggested an explant but the patient was concerned about explanting the lens after this many years.During follow up with the doctor he mentioned that he did not notice any opacification on the intraocular lenses, but there were posterior capsular opacities.It was mentioned that the patient had increased blurring in left eye for the past 2 months.The doctor noticed that when he checked her eyes this month again, he noticed significant pco on the residual posterior capsule affecting a large portion of the rings in the optic of the lens in the left eye.The patient is seeking further opinion on iol exchange.The doctor plans to perform supplementary yag post capsulotomy on the left eye if the patient does not plan to have iol exchange.No additional information was provided to abbott medical optics.Note: 2 mdr¿s will be submitted, one for each eye.This report pertains to the left eye.
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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7294602
• Report Number: 9614546-2018-00184
• Device Sequence Number: 11035498
• Product Code: MFK
• UDI-Device Identifier: 05050474536746
• UDI-Public: (01)05050474536746(17)150315
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2018

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: 03/15/2015
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 02/24/2018
• Supplement Report FDA Received Date: 04/09/2018
• 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
• Patient Age: 53 YR