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

Model Number	PCB00
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown if the lens was implanted.(b)(6).(b)(4).Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no other complaint was received from this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.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 the injector was handled incorrectly.The physician pushed the plunger up to the first line then screwed and pushed the lens in to the eye.The implant popped up and landed under the iris in the sulcus.The doctor tried to retrieve the lens to put the lens back in the broken capsule.The iris was torn.The implant went up the anterior chamber but as the chamber was narrow, the implant pasted to the endothelium.Which will require a corneal transplant.The surgery was also delayed by 30 minutes.Device is not available for investigation.No further information was provided.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no other complaint was received from this production order.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.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6546177
• Report Number: 2648035-2017-00794
• Device Sequence Number: 19019965
• Product Code: HQL
• UDI-Device Identifier: 05050474558489
• UDI-Public: (01)05050474558489(17)200125
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: 01/25/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 07/24/2017
• 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: 65 YR