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

Model Number	ZCB00
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a as the lens was inserted and removed during the same procedure.If explanted; give date: n/a as the lens was inserted and removed during the same procedure.Additional concomitant product: platinum injector lot# 020.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The intraocular lens (iol) was inserted into the right eye of a male patient.After insertion it was observed that the trailing haptic was torn.The lens was cut out of the eye and replaced with another implant.There was no incision enlargement.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in three pieces (including a detached haptic).This could be related to the removal process mentioned in the initial report.Manufacturing records review: the manufacturing records for the intraocular lens 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: the reported issue was not verified.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.Note: additional information has been received that clearly indicates there was no incision enlargement and that there was haptic damage (bent/broken).With this information, the file no longer meets reportability criteria.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6008166
• Report Number: 2648035-2016-01564
• Device Sequence Number: 80974
• Product Code: HQL
• UDI-Device Identifier: 05050474531581
• UDI-Public: (01)05050474531581(17)190921
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/21/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 11/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE LOT# CB35529
• Patient Age: 40 YR