MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: reported as 6 months ago.There is no indication of a lens explant at this time.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the patient is experiencing symptoms with the intraocular lens (iol) that was implanted in 2009.Reportedly, while snowflake debris/deposit appears on the lens and can not be lasered off with the yag laser.Patient complains of difficulty with filmy vision which began 6 months ago and is affecting both her eyes.The episode was gradual.The patient describes dry and hazy symptoms affecting her eyes/vision.The condition's severity is moderate.The patient experienced dry eyes which started 6 months ago and both eyes are affected.The episode is gradual and patient describes glazy and hazy symptoms affecting both eyes.The condition's severity has increased since the patient's last visit.The condition is worse with daily activities.The patient was to return for a diabetes follow-up on both eyes.Since her last visit, the affected area has no changes noted.The patient's vision is stable.The doctor will consider a lens exchange if the patient is still bothered with her visual acuity after her eye glasses prescription is updated.Patient's distance vision was 20/50 sc (sans corrected).No further information was provided.The patient has two lenses implanted; therefore, 2 mdrs will be filed.This report represents the lens implanted in the patient's left eye.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6408313
• Report Number: 2648035-2017-00495
• Device Sequence Number: 18846608
• Product Code: HQL
• UDI-Device Identifier: 05050474530782
• UDI-Public: (01)05050474530782(17)130531
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2013
• Device Model Number: Z9002
• Device Catalogue Number: Z900200245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 04/17/2017
• 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: Other