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

Model Number VICM5_13.2

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

Patient Problem Intraocular Pressure Increased (1937)

Event Date 12/23/2023

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm vicm5_13.2 implantable collamer lens of -5.50 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.The reporter reports observation of excessive vault and elevated intraocular pressure.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

B5- the reporter indicated that a 13.2mm vicm5_13.2 implantable collamer lens of -5.50 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.The reporter reports observation of excessive vault, elevated intraocular pressure and dislocation/subluxation.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.Claim # (b)(4).

Manufacturer Narrative

Additional information: b5: it was later reported that on (b)(6) 2024 the lens was exchanged with a shorter length lens and the problem was resolved.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18645384
• MDR Text Key: 334621273
• Report Number: 2023826-2024-00540
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/05/2024; 02/19/2024
• Supplement Dates FDA Received: 02/05/2024; 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2023
• 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 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female