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

Model Number VTICM5_13.2

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

Weight, ethnicity, race: unk.Pma/510k: this product is not marketed in the us.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated that a 13.2mm, vticm5_13.2, -13.0/+2.50/89, implantable collamer lens was implanted into the patients right eye (od) and removed on (b)(6) 2021, reason for removal is unknown.It was reported that there was no injury to the patient.On (b)(6) 2021 a replacement lens was implanted and the problem resolved.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

B5- the reporter indicated that a 13.2mm, vticm5_13.2, -13.0/+2.50/89, implantable collamer lens tore/broke during injection/delivery into the patient right eye (od) on (b)(6) 2021.The lens was removed intraoperatively with no injury to the patient.On (b)(6) 2021, a replacement lens was implanted and the problem 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12791923
• MDR Text Key: 280696386
• Report Number: 2023826-2021-04320
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2021
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female