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

Model Number VICMO12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endophthalmitis (1835)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vicmo12.6 implantable collamer lens of -10.5 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023, the lens was removed due to endophthalmitis.No diagnostics were performed.Treatment was performed.Reportedly, "we took out the lens and strengthened anti-inflammatory treatment." the problem was resolved.Cause of the event is unknown.

Manufacturer Narrative

Additional data: b5- the reporter indicated that the surgeon implanted a 12.6mm vicmo 12.6 implantable collamer lens of diopter -10.5 into the right eye (od) on (b)(6) 2023.The patient experienced endophthalmitis, uveitis, and medication was prescribed.Treatment was performed.On (b)(6) 2023 was explanted and the problem was resolved.Additional information provided: "the suggestion of consultation from fundus disease specialist considered uveitis more probably, related with icl toxic reaction.So we took out the len and strengthened anti-inflammatory treatment.Secondary icl implantation will plan after controlling the inflammation.Maybe 3 months or 6 months later".The reporter indicated the cause of the event is unknown.H6- health effect- clinical code: "2122" should be added.H6- type of investigation code: 3331- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).

• 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia 91016 ; 6263037902
• MDR Report Key: 17950145
• MDR Text Key: 325855457
• Report Number: 2023826-2023-04566
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/07/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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# UNK; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male