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

Model Number VTICM5_13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon reported a 13.2mm vticm5_13.2, -9.5/+1.5/102 (sphere/cylinder/axis) and the patient's right eye (od) on a complaint questionnaire.It is unknown as to whether the lens was implanted and/or removed.A shorter replacement lens is also reported.It is unknown as to whether this lens was implanted and the reason for the complaint is also not reported.Attempts to obtain additional information have not been successful.

Manufacturer Narrative

Additional information: b5- the reporter indicated that the surgeon implanted and removed a 13.2mm vticm5_13.2, -9.5/+1.5/102 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2019 intraoperatively.The lens was replaced with a shorter length lens within the same surgery due to excessive vault.The exchange resolved the problem.The reporter states that the "patient is happy!" the cause of the event is unknown.Claim# (b)(4).

Manufacturer Narrative

Corrected data: b1- "adverse event" ahould be corrected to "product problem" in the previous mdr h1- "serious injury" should be corrected to "malfunction" in the previous mdr.Additional information: h3 - device evaluation: lens returned in a micro centrifuge vial with residue and moisture on the lens.Visual inspection found the haptic torn and residue on the lens.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker ave.; monrovia CA 91016
• MDR Report Key: 9668837
• MDR Text Key: 190319498
• Report Number: 2023826-2020-00242
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: VTICM5_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: 06/23/2020
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 06/05/2020; 07/22/2020
• Supplement Dates FDA Received: 07/09/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL- SFC-45 LOT # UNK; INJECTOR MODEL- MSI-PF LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR