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

Model Number VTICMO13.2

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Not Applicable (3189)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm, vticmo13.2, -14.0/2.0/079 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault.This exchange resolved the problem.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H3 - device evaluation: the lens was returned in a micro-centrifuge vial with moisture on the lens.Visual inspection found no visible damage to the lens.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 91016
• MDR Report Key: 8816886
• MDR Text Key: 151888584
• Report Number: 2023826-2019-01217
• 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: 06/24/2019

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: 10/31/2021
• Device Model Number: VTICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Manufacturer Received: 06/23/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 08/21/2019; 12/06/2019
• Supplement Dates FDA Received: 08/21/2019; 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR