MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a patient had a zcb00 13.0 diopter intraocular lens (iol) implanted in the first eye in (b)(6) and the patient ended up -2.5 (reported great) spherical equivalent (se).The axial length for this eye is 26.3.The 2nd eye was done 2 weeks later and the axial length for the 2nd eye is 26.05 and so the physician went with a 13.5 diopter lens.However, the patient's post op refraction result was at +6.0 near distance.Through follow-up it was confirmed that the biometry of the patient between both eyes was fairly symmetric and immediate post-op refraction showed a significant hyperopic shift, which has remained consistent over the past 1.5 months.The physician has ruled out any macular pathology and stated there is no indication the iol is displaced, decentered, or tilted.The doctor believes the iol is mislabeled.They discussed evaluating the patient once again to check for marked steepening of the cornea, dry eye, other ocular surface issues.The physician stated he will likely proceed with an explant in near future and will return the iol in hopes of determining if the iol was indeed mislabeled.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation as the device remains implanted.However, the miq result was reviewed and the diopter measure was within the specification.The complaint was not verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaint for this production order number has been received.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6459225
• Report Number: 2648035-2017-00634
• Device Sequence Number: 10903464
• Product Code: HQL
• UDI-Device Identifier: 05050474531581
• UDI-Public: (01)05050474531581(17)190620
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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: 06/20/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/25/2017
• 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