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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was a removal and replacement in the initial procedure.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was initially reported that the patient had a vitrectomy performed associated with a zcb00 12.5 diopter intraocular lens (iol) in the left eye.Further information was provided and reported that there was also an incision enlargement as the lens was removed and replaced from the patients operative eye due to patient anatomy issues.Reportedly, there was no patient injury.A tear was reported in follow up, but it's unknown when the tear occurred.Also, it's unknown whether or not the lens was implanted at that time or during phacoemulsification.The lens was replaced with a sulcus lens.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on: 09/14/2017, 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 loose fibers/particles and residue of lubricant material on the lens indicating that the unit was handled and prepared for surgical use.No damaged was observed to the lens optic or the haptics.The customer's reported complaint could not be 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 investigation requests 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 92705
• MDR Report Key: 6867494
• Report Number: 2648035-2017-01659
• Device Sequence Number: 16307393
• Product Code: HQL
• UDI-Device Identifier: 05050474531567
• UDI-Public: (01)05050474531567(17)190331
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/03/2017
• 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