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

Catalog Number N/A

Device Problems Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Pain (1994); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Claim#: (b)(4).

Event Description

An article published "interface fluid syndrome after bioptics surgery" indicated that an implantable collamer lens was implanted into the patient's left eye (os) after lasik surgery.1 month postoperatively the patient complained of decreased vision; pain; and photophobia in the eye; hypertension (elevated iop).Patient was prescribed medication.At a later date slit lamp examination indicated severe corneal edema as well.It was later reported that after medication use the patient's eye was clear; iop was stable; medication was discontinued and the patient was discharged.The article concludes noting "we believe that the icl was not the direct cause of ifs; but rather it was the prolonged aggressive topical steroid use after icl in a steroid responder who had undergone lasik.Lens remains implanted.

• 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14605731
• MDR Text Key: 293447666
• Report Number: 2023826-2022-01798
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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
• Report Date: 05/13/2022

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: 05/13/2022
• Initial Date FDA Received: 06/06/2022
• 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
• Patient Sex: Male