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	Macular Edema (1822); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted; give date: na (not applicable) there is no indication that the lens was explanted.(b)(4).Device evaluation: the product testing could not be performed because the product was not returned for evaluation.Device inspection could not be performed, therefore the reported complaint could not be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints revealed no other complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: 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
A report was received that a patient that had a tecnis preloaded 1-piece monofocol model pcb00 intraocular lens (iol) implanted, experienced occlusive vasculitis due to an allergic reaction.The surgeon indicated that the patient had a delayed response with a vancomycin-like occlusive vasculitis, but the patient was not given antibiotics.Immediately after surgery, patient had cystoid macular edema (cme) then a few weeks later, occlusive vasculitis, then some retinopathy then the macula became white and all sorts of problems.No additional information was provided.

• 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: 7098531
• Report Number: 2648035-2017-02232
• Device Sequence Number: 1461727
• Product Code: HQL
• UDI-Device Identifier: 05050474558168
• UDI-Public: (01)05050474558168(17)190519
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/07/2017

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: 05/19/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/07/2017
• 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