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

Model Number VTICM5_12.6

Device Problem Misfocusing (1401)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.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, -2.5/5.0/41 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2018.Refractive surprise was observed.It was reported that repositioning of the lens is planned.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Event: the reporter indicated that a 12.6mm, vticm5_12.6, -2.5/5.0/41 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2018.Refractive surprise was observed.On (b)(6) 2018 repositioning of the lens was performed.It was reported that all is fine and the patient is happy.Patient code 3191: secondary surgical intervention, repositioning.Common device name should be corrected to phakic toric intraocular lens in original 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 91016
• MDR Report Key: 8067158
• MDR Text Key: 127078867
• Report Number: 2023826-2018-01672
• 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
• Report Date: 10/17/2018

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: 08/31/2021
• 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: 10/17/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL- SFC-45, LOT# UNK; FOAM TIP PLUNGER (FTP), LOT# UNK; INJECTOR MODEL- MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR