MAUDE Adverse Event Report: STAAR SURGICAL COMPANY; PHAKIC INTRAOCULAR LENS

Catalog Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Increased Sensitivity (2065); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Information entered into data fields due to requirement of esubmitter, however information is not known.This product is manufactured in the u.S.But is not marketed in the u.S.(b)(4).

Event Description

On (b)(6) 2017, staar became aware of a facebook review of a staar lens.The reporter stated that they had permanent damage done to one pupil, making the pupil of the left eye (os) permanently larger than the pupil of the right eye (od).Reporter also states good distance vision but is hyper-sensitive to light in the left eye and "sees colors differently." reporter states the damage is permanent.It is unknown whether the lens remains implanted.Attempts to obtain additional information have been unsuccessful.

Manufacturer Narrative

(b)(4).

• Brand Name: UNK
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6762426
• MDR Text Key: 81663086
• Report Number: 2023826-2017-01232
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

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
• Device Operator: No Information
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/02/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other