MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Device Problems Misfocusing (1401); Optical Problem (3001)

Patient Problems Cataract (1766); Eye Injury (1845); Flashers (1864); Glaucoma (1875); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Product code: unk; (b)(4); claim#: (b)(4).

Event Description

(b)(6) complaint: the patient reports that an implantable collamer lens was implanted in the left (os) eye in (b)(6) 2015.Reportedly, the patient experienced an increase in astigmatism, peripheral vision loss, poor night vision, and flashes.The patient states the surgeon has now diagnosed glaucoma, cataract, and optic nerve damage.Attempts to obtain additional information have not been successful.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 10936885
• MDR Text Key: 219322926
• Report Number: 2023826-2020-02829
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/02/2020
• 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