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

Model Number VTICM5_13.7

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated that a 13.7mm, vticm5_13.7, -10.5/5.5/102 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.The patient experienced excessive vault, lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information: b5: "patient's last visit was on (b)(6) 2020.Bcva 20/20; vault 900.Patient is happy.Lens remains implanted." (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: 10406783
• MDR Text Key: 202947655
• Report Number: 2023826-2020-01751
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: VTICM5_13.7
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 05/20/2021
• 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 Age: 26 YR