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

Model Number ICM V4

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

Patient Problems Macular Edema (1822); Uveitis (2122); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device manufacturing date: unk, no serial numbers reported.(b)(4).

Event Description

On 03 july 2019 we received notification of an article published in czech and slovak journal of ophthalmology entitled, 'incidence of cataract following implantation of posterior- chamber phakic lens icl (implantable collamer lens) long term results.' the article analyzes the results of icl implantation in 34 patients from 1998 to 2013.One such case references the recurrence of uveitis in one myopic eye.Uveitis occurred three times following implantation of an icm v4 lens, always approximately within an interval of one month, the last attack leading to the development of cystoid macular edema and papillary edema.The patient was repeatedly treated with corticoids locally and generally orally, once intravenously.One year after implantation of icl, the lens was explanted.Following the termination of corticoid therapy and three years after explantation of the icl , the patient underwent lasik for correction of refractive error.Now, 8 years after implantation of icl, the patients is without complaints, ucva in the right and left eye attains 1.0.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Patient code 3191 should have been included in initial mdr.Patient code 3191 corrected to: pupillary edema, medical intervention, explant, lasik.Patient code 1822 should have been included in initial mdr.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: 8847453
• MDR Text Key: 152972497
• Report Number: 2023826-2019-01276
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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
• Device Model Number: ICM V4
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention