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

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problems Cataract (1766); Corneal Edema (1791); Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

H6 - health effect clinical code: 4581 - ocular hypertension, cdva loss.Claim# (b)(4).

Event Description

An article published titled "efficacy and safety of implantable collamer lens v4c implantation in 1,834 myopic eyes for 1 year of follow-up", indicated that during this study there were multiple eyes with multiple patient experienced various adverse events.2 eyes had cdva loss at final follow up visit; 167 eyes had elevated intraocular pressure greater then 21mmhg; 18 eyes had ocular hypertension; 1 eye had reached 51.2mmhg with corneal edema and an additional surgery was performed to explant this lens.1 eye reached 39.6mmhg and medication was used as treatment; excessive or low vaulting occurred in 83 and 92 eyes.The article concludes visual outcomes of evo icl implantation were satisfactory in safety and efficacy indexes in both the low and high myopia groups.

Manufacturer Narrative

H6 - medical device problem code 1494: off-label use (under 21 yrs of age at date of implantation and over 45 yrs of age at date of implantation and acd < 3.0mm) added to 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
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 18295882
• MDR Text Key: 330111315
• Report Number: 2023826-2023-05541
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030016
• 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: 02/05/2024

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: 11/17/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/05/2024
• 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