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

Model Number VICM5_12.6

Device Problem Unintended Movement (3026)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

H6: type of investigation: lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).

Event Description

The reporter indicated that a 12.6mm vicm5_12.6 implantable collamer lens of -4.50 diopter was implanted upside down."lens flipped during injection 1st attempt.2nd attempt lens did not open correctly" was reported.The lens was implanted, removed and replaced intraoperatively.Problem resolved.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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
• MDR Report Key: 18808358
• MDR Text Key: 336570106
• Report Number: 2023826-2024-00910
• Device Sequence Number: 1
• Product Code: MTA
• 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
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VICM5_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: 02/02/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2022
• 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: INJECTOR MODEL: ACCUJECT, LOT #: 2337A2
• Patient Age: 40 YR
• Patient Sex: Male