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

Model Number VTICMO12.6

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

The product is manufactured in the us, but not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -8.5/+1.0/098 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged with a longer lens due to low vault.The problem was resolved.The cause of the event is reported as unknown.

Manufacturer Narrative

Additional information: h3-device evaluation: lens returned in a microcentifuge vial; dry.Visual inspection found haptic torn/bent/and deformed.(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
• MDR Report Key: 10496606
• MDR Text Key: 205905488
• Report Number: 2023826-2020-01972
• Device Sequence Number: 1
• Product Code: QCB
• 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
• Report Date: 08/09/2020

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: 05/31/2022
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 08/09/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR