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

Model Number VTICM5_12.6

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

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

The reporter indicated that a 12.6mm, vticm5_12.6, implantable collamer lens was implanted and removed within the same surgery with no patient injury.The reporter stated that during delivery into the eye the icl did not properly unfold.The reporter stated " the surgeon said it seemed that the lens was bigger than he thought.Also, because there was resistance when he pushed using plunger, he had difficulty manipulating the lens during the delivery.".

Manufacturer Narrative

H3- device evaluation: lens was returned in a micro-centrifuge vial with moisture on lens.Visual inspection found no visible damage to the lens.Claim #(b)(4).

Manufacturer Narrative

H3- device evaluation: lens was returned dry in a lens case/vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.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: 9753770
• MDR Text Key: 190644720
• Report Number: 2023826-2020-00383
• Device Sequence Number: 1
• Product Code: QCB
• 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,Followup
• Report Date: 01/29/2020

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: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/04/2020; 04/15/2020
• Supplement Dates FDA Received: 04/01/2020; 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR