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

Model Number VICM513.2

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

Patient Problem Uveitis (2122)

Event Type  Injury  

Manufacturer Narrative

Claim# (b)(4).

Event Description

The surgeon reports a case of uveitis three weeks after surgery.Per updated information the patient is doing well and the treatment ( eye drops) has solved the issue.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information: b5: the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 -5.50 diopter lens into the patients left eye (os) on (b)(6) 2023.Reportedly, iritis/uveitis/cme was observed three weeks after surgery.Per updated information the patient is doing well and the treatment (eye drops) has solved the issue.On (b)(6) 2023, excessive vaulting was reported.On (b)(6) 2023, the lens was explanted.This resolved the issue.Additional information reportedly, "approx 6 weeks post surgery all was perfect.On (b)(6) iritis was first diagnosed outside the clinic later dr.(b)(6) wrote in the patient file that there was no evidence of panuveitis.On (b)(6), a cme on both eyes was shown.Patient got "triam" (triamcinolon) parabulbar odos.On (b)(6), patient got much better, on (b)(6), all was fine again.On (b)(6), vaulting on od 1020 microns and os 912 micrones ucva 20/25 odos".H6: type of investigation: 4110 - al work order search found 2 similar complaints.Claim#: (b)(4) are duplicate claims of (b)(4).No similar complaint type events reported for units within the same lot.Claim#: (b)(4).

Manufacturer Narrative

Additional information: h3 - device evaluation: the lens was returned dry in a microcentrifuge vial with residue/debris on the lens.Visual inspection found no visible damage and residue on the lens.Dimensional inspection found the lens to be within specifications.Claim# (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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17877885
• MDR Text Key: 325005065
• Report Number: 2023826-2023-04419
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300846
• UDI-Public: 00840311300846
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2023

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: VICM513.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 01/15/2024; 03/27/2024
• Supplement Dates FDA Received: 01/23/2024; 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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
• Patient Outcome(s): Required Intervention