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

Model Number VTICMO13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); Pain (1994); Retinal Detachment (2047); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -18.00/+2.5/088 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2020.The lens was reported as being too big, the corners of the anterior chamber are closed, intraocular pressure is elevated, despite regular use of antihypertensive drugs and the patient complains of squeezing pain from time to time.There is also a retinal detachment.The cause of the event is unknown.The patients vision is normal and there are no strong complaints from patient.The lens remained implanted.

Manufacturer Narrative

Additional information: h6 - health effect clinical code: 4581 - yag pi, medical intervention outside standard protocol.H6 - health effect clinical code: 2047 should be removed.B5 - it was later confirmed by the reporter that the patient did not experience retinal detachment.Also additional yag surgeries were performed.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11478860
• MDR Text Key: 239685048
• Report Number: 2023826-2021-00635
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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: 06/30/2023
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/14/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR