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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cataract (1766); Dry Eye(s) (1814); Pupillary Block (2026); Retinal Detachment (2047)

Event Type  Injury  

Manufacturer Narrative

Unk, esubmitter does not allow you to put unk.(expiration date): unk, no serial number reported.(device manufacturing date): unk, no serial numbers reported.(b)(4).

Event Description

On (b)(6) 2020 we received notification of an article entitled, ' safety of phakic intraocular collamer lens (visian icl) implantation in 95 highly myopic special- needs children.' the article reports the following adverse events following icl implantation in children with special needs: adverse events for the visian icl cohort of 95 children and 160 implanted eyes.Minor events: steroid-response oht 2% (3) eyes, ciliary muscle spasm 1.2% (2) eyes, endothelial cell loss 4.0% per year in 31 eyes measured.Major events: pupillary block 4% (7) eyes, wound leak 0.6% (1) eyes, cataract 0.6% (1) eyes, retinal detachment 0.6% (1) eyes.Additional surgical intervention (revision of the peripheral iridotomy, wound leak repair, vicryl sutures, lens explant and pediatric cataract sugery, pars plana vitrectomy, intraocular laser retinopexy, gas/fluid exchange) and medical intervention (dorzolamide-timolol, cyclopentilate 1% drops, intravenous acetazolamide ) were performed/prescribed.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 11944308
• MDR Text Key: 264297595
• Report Number: 2023826-2021-01751
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2021

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: 05/07/2021
• Initial Date FDA Received: 06/05/2021
• 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): Required Intervention