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

Device Problems Contamination (1120); Misfocusing (1401); Off-Label Use (1494); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Edema (1791); Inflammation (1932); Blurred Vision (2137); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

An article was received that cited a retrospective clinical study that found 3 patients implanted with the posterior phakic implantable collamer lens (icl) and presented with toxic anterior segment syndrome (tass).All 3 patients were treated with medication and the inflammation disappeared.A possible cause was the handling of the icls or instrument tips with powdered-gloves as reported by the surgeon.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

Patient #1 experienced decreased vision, conjunctival hyperaemia and mild corneal edema.Multiple white deposits were located on the surface of the icl.Patient had keratoconus and previous intracorneal surgery which is off-label use with the icl lens.Patient #2 experienced conjunctival hyperaemia, corneal edema and decrease in vision.Patient #3 presented with 20/20 vision but with white deposits on the lens optic.(b)(4).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 91016
• MDR Report Key: 8593077
• MDR Text Key: 144530436
• Report Number: 2023826-2019-00757
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

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: 04/08/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 09/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention