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

Model Number VTICMO12.1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Glaucoma (1875); Intraocular Pressure Increased (1937); Pain (1994); Vomiting (2144); No Code Available (3191)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a 12.1mm, vticmo12.1, -18.0/+1.0/127 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019.On (b)(6) 2019 the lens was explanted due to angle closure with elevated iop.The reporter stated that the patient developed dense ac fibrinous inflammatory reaction, secondary glaucoma and right from implantation complained of severe pain, watering and vomiting.Patient was under steroids.It was reported that he problem has resolved.Cause of event was unknown.

Manufacturer Narrative

H3- device evaluation : lens was returned dry in a micro-centrifuge vial.Visual inspection found a torn haptic, residue and debris on the lens.Claim #: (b)(4).

Manufacturer Narrative

Corrected data: h6 - patient code 3191: no code available (angle closure, steroids).Claim#: (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: 9672545
• MDR Text Key: 177841331
• Report Number: 2023826-2020-00246
• 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,Followup
• Report Date: 01/07/2020

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: 06/30/2022
• Device Model Number: VTICMO12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 03/26/2020
• Supplement Dates FDA Received: 03/05/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45 W/FTP, LOT # UNK.; INJECTOR MODEL: MSI-PF, LOT # UNK.; CARTRIDGE MODEL: SFC-45 W/FTP, LOT # UNK; INJECTOR MODEL: MSI-PF, LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR