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

Model Number TMICL13.2

Device Problems Misfocusing (1401); Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  Injury  

Event Description

An implantable collamer lens was implanted into the patients eye and it was reported that there is a planned icl exchange.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Claim#: (b)(4).

Manufacturer Narrative

B5- per updated information the reporter indicated that a 13.2mm, tmicl13.2, -13.0/4.0/092 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2021.On (b)(6) 2022 the lens was exchanged for a different model and power lens due to refractive surprise and the problem resolved.It was reported that patient related factor was the cause of this event.The reporter also stated that the lens 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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15071012
• MDR Text Key: 301257017
• Report Number: 2023826-2022-02325
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542109499
• UDI-Public: 00841542109499
• 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: 06/21/2022

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: 05/31/2023
• Device Model Number: TMICL13.2
• 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: 06/21/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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: CARTRIDGE MODEL: SFC-45 LOT# 1518547; FTP. LOT# 1545951
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male