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

Model Number VTICM5_12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)

Patient Problems Intraocular Pressure Increased (1937); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -12.00/+2.5/085 (sphere/cylinder/axis), into the patients left eye (os).The lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A2: unk.A3: unk.A4: unk.A5: unk.A6: unk.B3: unk.D6a: unk.D6b: unk.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

B5: the lens was implanted on (b)(6) 2023.The lens was removed on (b)(6) 2023, due to high vaulting, causing pain and high pressure.The lens was replaced with a shorter lens and the problem was resolved.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
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17378095
• MDR Text Key: 319982710
• Report Number: 2023826-2023-03101
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542115278
• UDI-Public: 00841542115278
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2022
• 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: UNK.
• Patient Outcome(s): Required Intervention