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

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The intraocular lens (iol) was half injected and then removed when the patient moved.The technician tried to reload it and encountered loading issues which resulted in haptic breakage.An incision enlargement was required.A new iol was implanted (same model and diopter).The patient was doing fine post-op.There was no patient injury.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 04/18/2017.Device returned to manufacturer? yes.Device evaluation: the product was returned for evaluation.Fibers/particles were observed on the lens which is associated with the handling of the unit out of a sterile environment.Residue of viscoelastic were also observed on the lens and cartridge which indicates that the unit was handled and prepared for surgical use.The lens was observed stuck at the loading zone area.Both haptics were also observed broken and distorted inside the cartridge tube.The reported complaint issue haptic damaged was verified in the returned lens.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 provide the customer with proper usage instructions and guidelines.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: 6430250
• Report Number: 2648035-2017-00552
• Device Sequence Number: 10876498
• Product Code: HQL
• UDI-Device Identifier: 05050474530577
• UDI-Public: (01)05050474530577(17)201123
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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: 11/23/2020
• Device Model Number: Z9002
• Device Catalogue Number: Z900200140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 05/15/2017
• 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: 81 YR