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

Model Number VICM5 13.2

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that a 13.2mm, vicm5 13.2mm, -11.00 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.On (b)(6) 2020 the lens was removed, a replacement lens (same model,length and diopter) was later implanted.The reporter stated " the surgeon thinks that the problem is caused by lens error.He exchanged with the same lens and problem has resolved".Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information: h3- device evaluation: lens was returned dry with clear surgical debris in amicro centrifuge vial.Visual inspection found the optic and haptic orn with foreign debris on the lens.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9819379
• MDR Text Key: 189085457
• Report Number: 2023826-2020-00448
• Device Sequence Number: 1
• Product Code: MTA
• 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: 02/13/2020

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: 09/30/2022
• Device Model Number: VICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 06/01/2020
• Supplement Dates FDA Received: 06/30/2020
• 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 Outcome(s): Required Intervention