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

Model Number VTICMO13.2

Device Problems Material Integrity Problem (2978); 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.(b)(4).

Event Description

The reporter indicated the surgeon found a "line" on the lens surface of a 13.2mm vticmo13.2 implantable collamer lens, -13.00/+2.0/081 (sphere/cylinder/axis).The surgeon loaded the lens but was worried about the surgery effect and visual quality of the lens, so put lens back in the vial.The surgeon noted the lens was cracked in center of lens.The lens was not used and there was no patient contact.The replacement lens was implanted the next day and the problem was resolved.The patients current condition is great.The cause of the event was unknown.

Manufacturer Narrative

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

Manufacturer Narrative

H6 - work order search: no additional similar complaint type events within associated lots were found.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: 10135940
• MDR Text Key: 195406849
• Report Number: 2023826-2020-01168
• 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
• Report Date: 05/13/2020

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: 08/31/2022
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 05/11/2021
• Supplement Dates FDA Received: 08/19/2020; 05/11/2021
• 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: 27 YR