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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Cataract (1766); Corneal Edema (1791); Hyphema (1911); Intraocular Infection (1933); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

H6 - health effect clinical code: 4581 - lens impairment, iris prolapse, ocular hypertension, corneal endodermis damage, claim# (b)(4).

Event Description

An article published implantable collamer lens implantation (icl) versus small incision lenticule extraction (smile) in low to moderate myopia: study protocol for a randomized, non-inferiority trial - this study aimed to evaluated whether icl/ticl is comparable to smile for low to moderate myopia in terms of refractive outcomes at 3 and 18 months postoperatively.In this study it was indicated adverse events such as lens impairment, iris prolapse, hyphema, ocular hypertension, transient cornea edema, corneal endodermis damage, vault abnormality, surgery related cataract and intraocular infection, had occurred for patient with implantable collamer lenses.

Manufacturer Narrative

Corrected data: b5- originally the claim was determined to be reportable, but upon further review was determined to not meet definition of a complaint.However, the claim cannot be voided as an mdr has already been submitted.The article describes a prospective study that has not yet occurred.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: 17495099
• MDR Text Key: 320753011
• Report Number: 2023826-2023-03441
• 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: 07/19/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 10/26/2023
• 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): Other