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

Model Number VTICM5_12.6

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

Patient Problems Headache (1880); Vomiting (2144)

Event Date 08/22/2020

Event Type  malfunction  

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 12.6mm, vticm5_12.6, -8.00/1.5/068 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2020.Pressure 16mmhg, open angle, were observed.Headache and vomit were occasionally felt by patient.Lens remains implanted.Cause of the event is reported as unknown.Per the reporter on (b)(6) 2020, "surgeon is going to review patient in 1 month.No specific action, only observation for now." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

B5 - "reportedly, the surgeon thinks the cause of the headache and vomiting is due to the patient's adaptation of the vision." should be added to the initial mdr.B5 - "implantable collamer lens was implanted into the patient's right eye (os) on (b)(6) 2020." corrected to "implantable collamer lens was implanted into the patient's right eye (os) on (b)(6) 2020." in the initial mdr.Claim#: 717258.

• 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: 10548144
• MDR Text Key: 207558592
• Report Number: 2023826-2020-02092
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: N/A#S-P#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
• Report Date: 08/24/2020

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: 07/31/2022
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Patient Age: 31 YR