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

Model Number VTICM5_12.6

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Implant date: unk.Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.Device code: (b)(4).Claim#: (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -9.5/+2.5/069 (sphere/cylinder/axis) into the patient's left eye (os).On (b)(6) 2021 the lens was explanted and then replaced with an alternate lens.Attempts to obtain additional information have not been successful.

Manufacturer Narrative

B5-additional information: the initial lens was implanted on (b)(6) 2020.The lens was replaced with a longer lens due to low vault.Unaided va is 6/6 after replacement.Reportedly the vault is still low.Reference mfr file# (b)(4) for replacement lens.The cause of the event is reported as user error; the device did not fail to perform as intended.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 13122736
• MDR Text Key: 286443109
• Report Number: 2023826-2021-05002
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

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: 01/31/2023
• Device Model Number: VTICM5_12.6
• 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: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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-MSI-TF, LOT#-UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male