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	Intraocular Pressure Increased (1937); Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	04/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was inserted and removed.(b)(4).Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed.The reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints for this production order number has been received.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zcb00 32.0 diopter was inserted and removed from a male patient's eye due to high intraocular pressure.Through follow up, the customer stated that she does not believe the lens contributed to the patient having high pressure and is most likely due to the patient.Customer indicated that a vitrectomy was performed and the physician noticed the high pressure.There was no incision enlargement.Additionally, the customer stated that after the lens was implanted the surgeon discovered a posterior capsule rupture.There was no replacement lens available.The physician also noted that the patient had a prolapse and the cornea was cloudy.The patient was doing fine when discharged.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6652237
• Report Number: 2648035-2017-01094
• Device Sequence Number: 13774384
• Product Code: HQL
• UDI-Device Identifier: 05050474531956
• UDI-Public: (01)05050474531956(17)201116
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/19/2017

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: 11/16/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/19/2017
• 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: 76 YR