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

Model Number VTICMO13.2

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Corneal Clouding/Hazing (1878)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -07.00/+3.5/068 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2021.The lens was reported as lens rotation not associated to a low vault.The lens remained implanted.The cornea was a bit hazy.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Additional data: b5: the lens was repositioned on (b)(6) 2021 but the problem was not resolved.The lens was explanted on (b)(6) 2021 and replaced with a longer lens but the problem was not resolved.The lens had rotated again and was removed and replaced with a mfiol.See mfr.Report#: 2023826-2021-03263 for replacement lens.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: 11937992
• MDR Text Key: 254263548
• Report Number: 2023826-2021-01756
• 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: 05/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/28/2021
• 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-TF - LOT # UNK.; UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR