MAUDE Adverse Event Report: OPHTEC BV ARTISAN; PHAKIC LENS

Model Number 205

Device Problem Insufficient Information (3190)

Patient Problem Macular Edema (1822)

Event Date 03/31/2016

Event Type  Injury  

Event Description

Cystoid macular edema was noted through optical coherence tomography exam.

• Brand Name: ARTISAN
• Type of Device: PHAKIC LENS
• Manufacturer (Section D): OPHTEC BV; groningen 9728 NR N; NT 9728 NR NL
• MDR Report Key: 5570119
• MDR Text Key: 42512124
• Report Number: MW5061612
• Device Sequence Number: 1
• Product Code: MTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 205
• Device Lot Number: 104656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR