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

Model Number VICM5_12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Edema (1791)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

A4 - unk, a5 - unk, a6 - unk, h6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6, -8.5 diopter, implantable collamer lens, into the patient's left eye(os) on (b)(6) 2024.The lens was explanted on (b)(6) 2024 due to trace of corneal edema.The problem was resolved.Cause of the event is reported as unknown.Reportedly, patient very happy with vision.Reportedly, corneal edema nearly fully7 resolved and much improved.

Manufacturer Narrative

Disregard initial mdr, it was later verified to be n/a.

• 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: 18738701
• MDR Text Key: 335752044
• Report Number: 2023826-2024-00704
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300570
• UDI-Public: 00840311300570
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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: VICM5_12.6
• 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: 01/29/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2023
• 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: CARTRIDGE MODEL#SFC-45,LOT#1660106.; FOAMTIPPLUNGER MODEL#FTP,LOT#1710776.; INJECTOR MODEL#MSI-PF,LOT#1390762.
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female