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 Corneal Decompensation (1790); Pain (1994); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A (b)(6) woman presented with foggy vision and intolerance to bright light since 10 months with her best-corrected visual acuity (bcva) in the right eye 20/30.She underwent implantable collamer lens insertion 10 months ago in the right eye and reported blurry vision from first day postoperative which did not improve.Foggy vision, photophobia, watering and pain in the right eye worsened over a period of 7 months during which she took a break from work and was under conservative management with topical pred-nisolone 1% in tapering dose, moxifloxacin 0.5%and hypertonic saline nacl 5% drops.Dmek was performed and at 8 months she had a bcva of 20/20 and ecd 1504 cells/mm2 with a reduction of 38.18% cells and iop of 14 mm hg.The cornea was clear and the icl was in a normal position with adequate vault and a clear crystalline lens.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: b5 - patient had corneal decompensation.Should have also been included.H6 - health effect clinical code 4581: photophobia, endothelial cell loss.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 12072306
• MDR Text Key: 259197607
• Report Number: 2023826-2021-02037
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 05/26/2021

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: 05/26/2021
• Initial Date FDA Received: 06/26/2021
• Supplement Dates Manufacturer Received: 02/10/2022
• Supplement Dates FDA Received: 02/10/2022
• 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