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

Model Number VTICM5_12.6

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)

Patient Problems Corneal Edema (1791); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); No Code Available (3191)

Event Date 04/08/2019

Event Type  Injury  

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, -3.00/3.5/007 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019.Blurred vision, "painful, and red eye" was observed.Lens was removed on (b)(6) 2019.Cause of the event is reported as "the sizes of the lens probably too big." per patients last visit on (b)(6) 2019, "reduced vision left eye still rigid big pupil, iris defect as 13.00, corneal edema 201090410, rigid pupil has not returned to normal size." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Patient code 3191 - iris defect and fixed pupil.Device codes 3001 and 1583 that were previously reported are not applicable.Common device name/ product code corrected.Mta product code in initial mdr not applicable.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: 8860009
• MDR Text Key: 153242129
• Report Number: 2023826-2019-01291
• 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: 07/11/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• 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: 07/11/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/04/2019
• 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; CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR