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 Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm, vticmo12.6, -8.0/2.5/090 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a longer length lens due to low vault.This exchange resolved the problem.

Manufacturer Narrative

Patient code:3189 should be corrected to 3191 in inital medwatch report.Claim#: (b)(4).

Manufacturer Narrative

Concomitant medical products: foam tip plunger model-ftp; lot#-unk should have been included in initial medwatch report.Device code 1494: off-label use (acd < 3.0mm) should have been inlcuded in initial medwatch report.Claim#: (b)(4).

Manufacturer Narrative

H3-device evaluation: the lens was returned in a micro-centrifuge vial with moisture on the lens.Visual inspection found no visible damage to the lens.(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: 8816887
• MDR Text Key: 151888876
• Report Number: 2023826-2019-01219
• 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,Followup
• Report Date: 06/27/2019

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: 09/30/2021
• 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: 12/23/2019
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 09/18/2019; 09/30/2019; 01/14/2020
• Supplement Dates FDA Received: 09/18/2019; 09/30/2019; 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45, LOT# UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL: MSI-PF, LOT # UNK; CARTRIDGE MODEL: SFC-45, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR