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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Uveitis (2122); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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).
Additional Manufacturer Narrative
Additional information: b5-the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -8.00/1.5/093 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced uveitis/iritis that started off as toxic anterior segment syndrome (tass).Reportedly "unusual fibrinous reaction/ inflammation".Diagnostics (tap for culture which was negative) and treatment (moxi +a/c washout) was performed medication was prescribed.The lens remains implanted and the problem was resolved.Reportedly "the good news is he's doing great now and is so happy with the vision.Fortunately at it's worse the vision was 20/150 (as opposed to hand motion) and quickly improved with treatment.I think the same day a/c washout helped.He looked quite a bit better even the next day.Certainly best case scenario for this kind of event."the reporter indicated the cause of the event is unknown.H6- 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.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: 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
• Report Number: 2023826-2023-05725
• Device Sequence Number: 2634919
• Product Code: QCB
• UDI-Device Identifier: 00841542114691
• UDI-Public: 00841542114691
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 06/09/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/19/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male