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

Model Number VTICM5_12.6

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

Patient Problems Inflammation (1932); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

A4: unk a5: unk a6: unk d6b: unk h6: health impact - additional surgery: 4625 - anterior chamber irrigation/evacuation of visco/fluids (a/c washout).H6: health effect impact code: 4644 - prednisolone, moxifloxacin, bromfenac compound drops, medrol dose pack.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -08.00/+1.5/093 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2023.At 5 days post-op, toxic anterior segment syndrome (tass) (fibrin and 3+ cell) was observed.Tap for culture was performed and was negative.Prednisolone, moxifloxacin injection and bromfenac compound drops were administered.Anterior chamber irrigation/evacuation of visco/fluids was performed (a/c washout).Patient was started on medrol dose pack.Post-op the patient has excellent vision and iop, with only trace residual inflammation.The problem was resolved.The cause of the event was unknown.The lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

B5: five day post-op patient vision in left eye (os) was 20/150.The patient improved quickly with treatment.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18387531
• MDR Text Key: 331289665
• Report Number: 2023826-2023-05725
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542114691
• UDI-Public: 00841542114691
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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: VTICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2023
• 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
• Patient Age: 35 YR
• Patient Sex: Male