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

Model Number VICM5_13.2

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Blurred Vision (2137)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -3.5 diopter into the patient's right eye (od) on (b)(6) 2020.The surgeon reports excessive vault, elevated iop, and puntiform opacity in the posterior capsule.The cause of the event is reported as user error: non recommended ovd and excessive use of ovd due to a non total dilation during surgery.Anterior chamber irrigation/evacuation of visco/fluids was performed.Reportedly, the iop was managed after the evacuation of ovd.Puntiform opacity has decreased after 48 hours of surgery.

Manufacturer Narrative

B5-updated information: reportedly, the problem is now resolved.(b)(4).

Manufacturer Narrative

B5.Elevated iop is an expected or foreseeable side effect.(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
• MDR Report Key: 11098622
• MDR Text Key: 224530653
• Report Number: 2023826-2020-03254
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2020

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 Expiration Date: 09/30/2023
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/31/2020; 08/04/2021
• Supplement Dates FDA Received: 01/27/2021; 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-1495754; FOAM TIP PLUNGER MODEL-FTP, LOT#-1487150; INJECTOR MODEL-MSI-PF, LOT#-1498053
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR