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

Model Number VTICMO12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

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

A lens tear/break before loading on a 12.6mm, vticmo12.6, -13.5/3.5/089 (sphere/cylinder/axis) implantable collamer lens was reported.It was reported that the damage was noted while removing from vial.The lens was implanted into the patients left eye (os) and removed within the same surgery.On (b)(6) 2020 a replacement lens was implanted and the problem was resolved.Cause of event is unknown.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected dat: b4-date of this report in initial mdr should be corrected to (b)(6) 2020 g4- date received by manufacturer in initial mdr should be corrected to (b)(6) 2020 claim# (b)(4).

Manufacturer Narrative

Additional information : h3: device evaluation: lens returned in a microcentrifuge vial with moisture.Visual inspection found no visible damage to lens.Claim# (b)(4).

Manufacturer Narrative

Additional information : b5- the reporter indicated that a 12.6mm, vticmo12.6, -13.5/3.5/089 (sphere/cylinder/axis) implantable collamer lens tore/broke while removing from vial on (b)(6) 2020.The lens was not implanted.There was no patient contact.On (b)(6) 2020 a replacement lens was implanted and the problem was resolved.D6-implant date (b)(6) 2020 in initial mdr is not applicable.D7-explanted date (b)(6) 2020 in initial mdr is not applicable.Corrected data h6-patient code 2692 in initial mdr is corrected to 2645.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
• MDR Report Key: 10225159
• MDR Text Key: 199989277
• Report Number: 2023826-2020-01385
• 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,Followup,Followup
• Report Date: 06/05/2020

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: 12/31/2021
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 08/24/2020; 10/08/2020
• Supplement Dates FDA Received: 08/20/2020; 09/23/2020; 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# 1411943; FTP, LOT# 1411930; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Age: 28 YR