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

Model Number VICM5_12.1

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated a 12.1mm vicm5_12.1 implantable collamer lens, -09.00 diopter, tore/broke during injection/delivery into the patient's right eye (od).There was patient contact but no injury.The lens was replaced with another same model/length lens and the problem was resolved.

• 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 ; 6263037902
• MDR Report Key: 19217931
• MDR Text Key: 341518446
• Report Number: 2023826-2024-01912
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300259
• UDI-Public: 00840311300259
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

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_12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2023
• 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 # 1635508; FOAM TIP PLUNGER MODEL FTP - LOT # 1646592; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Age: 28 YR
• Patient Sex: Male