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 Problem Iritis (1940)

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(device manufacturing date): unk, no serial numbers reported.Claim #: (b)(4).

Event Description

On (b)(6) 2021 we received notification of an article entitled,' a direct observation of aqueous humor flow vivo after implantable collamer lens with a central hole implantation ' the article reports a case of iridocyclitis following icl implantation.The article states "a (b)(6) year-old female complained of mild vision blurring in the left eye (os) and was diagnosed with iridocyclitis at postoperative 2wk after bilateral spherical icl with a central hole implantation for high myopic correction.A slit-lamp examination without the pupil dilated showed anterior chamber inflammation, and the grading of the aqueous flare was 4+." it was reported that tobramycin-dexamethasone eye drops were used topically, six times a day for 1d and then four times a day for 7d.When patient visited the clinic again, she had no complaints, udva was 20/20, the aqueous flare disappeared from the anterior chamber, and the aqueous humor became transparent.It was reported that the patient demonstrated a good prognosis after 8-month follow-up exam.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 11427354
• MDR Text Key: 242060831
• Report Number: 2023826-2021-00574
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2021

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: 02/04/2021
• Initial Date FDA Received: 03/07/2021
• 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