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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation not associated to a low vault.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
D4: expiration date unk.H11: lens rotation is identified in the labeling as a known potential adverse event following icl implantation.Claim # (b)(4).
Additional Manufacturer Narrative
B5: the surgeon decided to rotate the lens but the outcome was still not good.The lens remains implanted.Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: h6 - work order search: no similar complaint was reported for units within the same lot.Corrected data: b5: a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation not associated to a low vault and a refractive surprise.The lens was repositioned but the problem was not resolved.Due to lens rotation not associated to a low vault and refractive surprise, the lens was removed and replaced intraoperatively for another same model/length but different power lens.The problem was resolved.Cause of event was reported as unknown.Claim # (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned dry in a microcentrifuge vial.Visual inspection found no visible damage to lens.Dimensional and functional inspection found the lens to be within specifications.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: 20081171
• Report Number: 2023826-2024-03723
• Device Sequence Number: 7838085
• Product Code: QCB
• UDI-Device Identifier: 00840311308972
• UDI-Public: (01)00840311308972(11)240207(17)270131
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 12/24/2024; 08/15/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/18/2024; 01/23/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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.; INJECTOR MODEL AND LOT # UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female