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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.Date of event: unknown.If implanted, give date: unknown/ not provided.If explanted, give date: not applicable as there is no indication that the lens was explanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a physician had 2 patients who had inflammation and possible toxic anterior segment syndrome (tass).One event occurred in march and the other occurred in (b)(6).It was reported that they did a full review and the only thing found in common was the lens.They both had a pcb00 lens.No further information was provided.This report will capture the pcb00 11.0 diopter intraocular lens (iol) and separate mdr will be filed for the second pcb00 lens.No further information was provided.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Device inspection could not be performed.The reported issue was not confirmed.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 as product met manufacturing release criteria.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: 6627483
• Report Number: 2648035-2017-01027
• Device Sequence Number: 896027
• Product Code: HQL
• UDI-Device Identifier: 05050474558083
• UDI-Public: (01)05050474558083(17)190421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2017

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: 04/21/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/07/2017
• 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: Other