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

Model Number VTICMO13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)

Patient Problems Visual Disturbances (2140); Halo (2227); No Code Available (3191)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -7.0/+1.5/108 (sphere/cylinder/axis), into the patient's right eye (od) on (b)(6) 2020.The surgeon reports excessive vault, small anterior chamber and glare/halos.Reportedly, the lens remains implanted.The cause of the event is reported as unknown.

Manufacturer Narrative

Additional information: b5- "lens was exchanged on (b)(6) 2020 with a shorter length lens due to excessive vault.This resolved the problem." h3- device evaluation: lens was returned in a vial in liquid with debris on the lens.Visual inspection found the haptic torn with debris on the lens.H6- device impact code 4629- lens exchange.Claim# (b)(4).

Manufacturer Narrative

Corrected data: "h6- device history record- based on the results of the investigation all released devices from the associated work word(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue." should have been in the previous mdr.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
• MDR Report Key: 10491985
• MDR Text Key: 209373529
• Report Number: 2023826-2020-01969
• 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: 08/10/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 08/10/2021
• Supplement Dates FDA Received: 05/27/2021; 09/01/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR