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

Model Number VICM5 12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.Pma/510k: this product is not marketed in the u.S.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a 12.6mm, vicm5_12.6, -7.00 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.The lens was removed and replaced with back up lens within the same surgery due to lens stuck in cartridge.There was no patient injury.Cause unknown, the reporter stated " the lens stuck in the cartridge because the surgeon tried to push the lens with the plunger from the back of the cartridge into it.He was not using the icl loading forceps as we've recommended.".

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial with moisture on the lens, with debris on the lens.Visual inspection found the lens haptic torn with debris on the lens.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 10485131
• MDR Text Key: 216876098
• Report Number: 2023826-2020-02013
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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: 03/31/2023
• Device Model Number: VICM5 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/15/2020
• 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
• Patient Age: 23 YR