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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cataract (1766)

Event Type  Injury  

Event Description

An article was published in j korea ophthalmol soc titled, "long-term clinical outcome of implantable collamer lens." the article stated that this retrospective study included 129 eyes of 68 patients who underwent implantable collamer lens (icl) implantation of myopia with a 10 year follow up."eight eyes (6.2%) developed cataract during follow-up, which was symptomatic in three eyes (2.3%) and treated with icl explantation and phacoemulsification.Rhegmatogenous retinal detachment occurred in one eye (0.8%) and was treated with vitrectomy.".

Manufacturer Narrative

Weight - race:unk.This product is not marketed in the us (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
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14165251
• MDR Text Key: 289734464
• Report Number: 2023826-2022-01220
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/21/2022
• 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): Required Intervention