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

Model Number	Z9002
Medical Device Problem Codes	Bent (1059); Break (1069); Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that after insertion of a z9002 28.0 diopter intraocular lens (iol) into the left eye of a patient, it was observed that the lens appeared cracked by the haptics (both pieces/sides).In addition it was indicated the haptic was bent/broken.The lens was removed, the incision was enlarged, a 10.0 nylon suture was used to close the wound.It is noted that the patient has recovered.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 3/21/2017.Device returned to manufacturer? yes.Device evaluation: visual inspection at 10x microscope magnification was performed.Fibers/particles were observed on the lens which is related to the handling of the unit out of a non-sterile environment.Residue of viscoelastic were also observed on lens pieces which indicates that the unit was handled and prepared for surgical use.The lens was returned cut in two pieces.One of the haptics was observed distorted.The reported issue was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6405068
• Report Number: 2648035-2017-00486
• Device Sequence Number: 759166
• Product Code: HQL
• UDI-Device Identifier: 05050474530850
• UDI-Public: (01)05050474530850(17)201103
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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: 11/03/2020
• Device Model Number: Z9002
• Device Catalogue Number: Z900200280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• 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: Required Intervention
• Patient Age: 78 YR