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

Model Number VICMO13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

H6 - health effect clinical code: 4581 - shallow ac, narrow angles, significant reduction of irido-corneal angles.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2; -17.00 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.The patient experienced excessive vaulting, difficult near vision, shallow ac, refractive surprise, elevated intraocular pressure, narrow angles, significant reduction of irido-corneal angles, glare/haloes, blurred vision.The lens was explanted and replaced with a shorter/different power lens.

Manufacturer Narrative

Corrected data: b5- the reporter indicated the surgeon implanted a 13.2mm vicmo 13.2 implantable collamer lens of diopter -17.0 into the patient's right eye (od) on (b)(6) 2024.The patient experienced excessive vault, elevated iop, glare/haloes, refractive surprise, loss of visual acuity, significant reduction in iridocorneal angles, narrow angles, shallow ac and blurred vision.Reportedly "the doctor decided to exchange the lens with -14.00 lens and 12.6 diameter" and "the patient is better now".The reporter indicated the cause of the event is unknown.H6-health effect- impact code: "4627" should be removed and code "4629" should be added.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: 18767992
• MDR Text Key: 336116878
• Report Number: 2023826-2024-00803
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 02/02/2024

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
• Device Model Number: VICMO13.2
• 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: 02/02/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/05/2024
• Date Device Manufactured: 04/07/2022
• 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