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

Catalog Number N/A

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Optical Problem (3001)

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Retinal Detachment (2047); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

An article titled "causes of phakic implantable collamer lens explantation/exchange at (b)(6) hospital", indicated that or 787 icl implants, 30 implants were explanted.The causes of the explant included incorrect lens size, cataract, high residual astigmatism, rhegmatogenous retinal detachment, glare, corrective measures mainly included exchange with an appropriately sized lens, phacoemulsification and posterior chamber intraocular lens implantation, or replacement of icl with correct power.Incorrect icl size was the most common cause of explantation.

Manufacturer Narrative

Claim# (b)(4).

Manufacturer Narrative

Corrected data: b5 - "it additionally notes there were cases that included elevated intraocular pressure, lens rotation, shallow ac, pas in this study." -should have been included in the initial medwatch report.H6 - health effect clinical code: 4581 - shallow ac, pas.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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17007063
• MDR Text Key: 315997046
• Report Number: 2023826-2023-02047
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2023

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 Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/11/2023
• 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