MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Patient reported that she received bilateral tecnis multifocal lens implants with her cataract surgery.Her vision is now cloudy and very blurry and it is very difficult to read print and computer screens; there is always glare.Patient noted she had lasik surgery in the past.Additional information was obtained from the surgery center.At the patient's last follow-up, the patient's uncorrected visual acuity (ucva) for both eyes was 20/40.The doctor's diagnosis is posterior capsule fibrosis and he is thinking that this may be the contributing factor to the patient's blurry vision, dryness and other visual issues.Treatment given was medication for dryness.Doctor gave patient medical treatment for dryness.Doctor also indicated in the chart that there's nothing in question with the implanted lens.He referred the patient to a retina specialist for further work-up on the patient's visual concerns.He also stated that the patient may need yag (yttrium-aluminum-garnet) laser for future treatment.The zmb00 lens implanted in the patient's left eye is being captured in this report and a separate mdr is being filed for the zlb00 lens implanted in the right 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 similar 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 abbott medical optics has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5992337
• Report Number: 9614546-2016-00488
• Device Sequence Number: 93168
• Product Code: MFK
• UDI-Device Identifier: 05050474535640
• UDI-Public: (01)05050474535640(17)181217
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2016

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: 12/17/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 12/02/2016
• 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