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

Model Number VICM5_12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Optical Problem (3001)

Patient Problems Intraocular Pressure Increased (1937); Visual Disturbances (2140); Halo (2227)

Event Date 10/28/2023

Event Type  Injury  

Manufacturer Narrative

H6 - work order search: no similar complaint was reported for units within the same lot.Claim#: (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens, -09.50 diopter, into the patients right eye (od) on (b)(6) 2023.The lens was removed on (b)(6) 2023 due to low vaulting, elevated intraocular pressure (iop), lens dislocation/subluxation and glare/halos.The lens was repositioned on (b)(6) 2023 but the problem was not resolved and the lens was removed.The lens was replaced with a longer lens and the problem was resolved.Cause of the event was the device.

• 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 ; 6263037902
• MDR Report Key: 18632502
• MDR Text Key: 334493302
• Report Number: 2023826-2024-00277
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300594
• UDI-Public: 00840311300594
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Report Date: 01/12/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2022
• 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
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male