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

Model Number VICM5_12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated a 12.6mm vicm5_12.6 implantable collamer lens, -9.50 diopter, was torn while being pulled through the cartridge during the loading process.There was no patient contact.The lens was exchanged for another same model/length lens on (b)(6) 2020 and the problem was resolved.The patient is happy.The cause of the event was unknown.

Manufacturer Narrative

Additional information : h3-device evaluation: lens returned in a micro-centrifuge vial with moisture on the lens.Visual inspection found optic torn and haptic torn.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: 10135965
• MDR Text Key: 194649355
• Report Number: 2023826-2020-01169
• 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: 05/15/2020

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: 09/30/2022
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Age: 38 YR