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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

Patient Problems Headache (1880); Intraocular Pressure Increased (1937); Halo (2227); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

A2: unk, a4: unk, a5: unk, a6: unk, b3: unk, d4: expiration date unk, d6a: unk, d6b: na, e3: unk, h4: unk, h6: health effect impact code - medication required: 4644 - lumigan, combigan, steroid drops, oral diuretic.Claim # (b)(4).

Event Description

The patient reported through social media, she had an icl implantable collamer lens implanted in left eye (os).At one week post-op, the patient reported was experiencing halos at night.At three week post-op, was experiencing pain and bad migraines.The intraocular pressure (iop) was found to be 55mmhg and patient was prescribed lumigan, combigan, steroid drops and oral diuretic.The combigan was discontinued due to patient had bad reaction.The steroid drops were also discontinued.At four weeks post-op, the iop was 11mmhg and patient was taking one drop of lumigan and one diuretic a day.There were no more migraines and halos had improved.At seven months post-op, there were no halos or iop problems.Patients vision was 20/20.The lens remained 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 muniz ; 1911 walker avenue; monrovia, CA 61016 ; 6263037902
• MDR Report Key: 18670895
• MDR Text Key: 334949915
• Report Number: 2023826-2024-00481
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: Asian