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

Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)

Patient Problems Cyst(s) (1800); Iritis (1940); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated the surgeon implanted an icl implantable collamer lens, in the patients left eye (os) on (b)(6) 2019.The reporter indicated the lens had a high vault and bowed forward iris.There was some persistent iritis and maybe vertical tilt.The patient is doing ok on prednisolone, which will be tapered off over next few weeks.The lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

Additional data: b5: the reporter indicated after reviewing an arcscan, it showed a possible cyst causing the tilt, so this is not likely due to the device.No explantation is planned for now and the patient is happy.Claim # : (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9753514
• MDR Text Key: 181328245
• Report Number: 2023826-2020-00376
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2020

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: 01/26/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other