MAUDE Adverse Event Report: STAAR SURGICAL EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS; PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM5 13.2 (-12/2.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Corrected data: h6 - health effect clinical code: 4581 - unreactive fixed pupil, pigment dispersion.Additional information: b5 - a facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced uveitis/iritis, possible moxi induced dispersion, blurred vision, unreactive fixed pupil, elevated intraocular pressure, medication was used, glaucoma, iris atrophy, the lens was explanted and ac wash out was performed along with glaucoma procedure.It was noted this was a sequential bilateral procedure, with no pre-existing conditions.Medication was prescribed 4 times a day for 1 week.It was noted the cause of the event was reported as the device and "this patient's surgery was atraumatic and there were no intraoperative issues.The vault was ideal.Yet, the patient presented a few weeks after surgery with intense pigment dispersion, pigment dispersion glaucoma, and eventual pupil abnormalities (decreased reactivity) and iris atrophy.I suspected icl-ugh, however it was suggested it was the moxifloxacin.It was additionally noted the patient had severe headache and pain ahead of the glaucoma surgery.The patient is still being monitored and the final outcome is unknown.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: iritis is an inflammatory condition which is common after intra-ocular surgery, however this is usually mild and does not require any additional interventions beyond the standard post-op regimen.In some cases, the degree of inflammation may be more severe and require extended steroid treatment.Procedural factors including excessive surgical manipulation and the use of pro-inflammatory substances in the eye may have contributed to the event.Mechanical insult to the iris can result in a prolonged or stronger inflammatory response.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Non-reactive pupil, iop elevation from baseline, uveitis/iritis, secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim#: (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced possible moxi induced dispersion and elevated iop.Cause of the event was reported as unknown.No further information has been provided.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
A4-a6: unk claim #(b)(4).
Additional Manufacturer Narrative
Additional information: h6 - type of investigation 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: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 21727230
• Report Number: 2023826-2025-00482
• Device Sequence Number: 17096064
• Product Code: QCB
• UDI-Device Identifier: 00840311312061
• UDI-Public: (01)00840311312061(11)240708(17)270630
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2025

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 Model Number: VTICM5 13.2 (-12/2.5)
• Device Catalogue Number: VTICM5 13.2
• Device Lot Number: N/A
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 05/06/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/30/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female