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

Model Number	ZCB00
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that one haptic of an intraocular lens (iol) was sheared off during insertion into the eye.The lens was injected into the capsule and it was cut in half to be removed.The incision was enlarged and a 10-0 nylon suture was used to close the wound.The damaged lens was replaced with another lens, same model and diopter.Additional information revealed that there was no additional patient injury.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 04/13/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that the lens was cut in two pieces, as a result of the removal/explant process.One haptic was observed detached from the lens body.The customer's reported complaint was verified manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics 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: 6275193
• Report Number: 2648035-2017-00166
• Device Sequence Number: 153403
• Product Code: HQL
• UDI-Device Identifier: 05050474531550
• UDI-Public: (01)05050474531550(17)200330
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2017

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: 03/30/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 05/04/2017
• 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 UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention