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

Model Number VTICM5_13.7

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that a 13.7mm vticm5_13.7 of -11.00/3.5/078 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was removed due to excessive vault.A replacement lens of shorter length was later implanted and the problem resolved.In the reporter opinion the cause for this event was the device." lens too large, causing discomfort" was reported for cause details.

Manufacturer Narrative

Corrected data: h6-health effect- impact code: "4629" should be removed and code "4627" should be added.B5- the reporter indicated that the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens of diopter -11.00/3.5/078 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault and discomfort.On (b)(6) 2023 the lens was explanted and later replaced with the shorter length and the problem was resolved.The reporter indicated the cause of the event is device- "lens too large, causing discomfort'.Claim# (b)(6).

• 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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17453736
• MDR Text Key: 320337896
• Report Number: 2023826-2023-03240
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542118378
• UDI-Public: 00841542118378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

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 Model Number: VTICM5_13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INJECTOR MODEL: LIOLI-24, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female