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

Model Number	VTICM5 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticm5 implantable collamer lens of -10.00/+1.50/090 power (sphere/cylinder/axis) into the patient's right eye (od) on an unknown date.Reportedly, "patient is experiencing inflammation in the right eye." to the best of our knowledge the lens remains implanted.No further information has been provided.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
A4-a6: unk.Manufacturer narrative: a review of the device labeling was completed.Iritis is identified in the labeling as known potential adverse events following icl implantation.The directions for use adequately provides surgeons instruction for icl implantation which states: as with implantation of other types of intraocular lenses, potential adverse events can include, but are not limited to infection (endophthalmitis), hypopyon, corneal endothelial damage, iol dislocation, cystoid macular edema, corneal edema, pupillary block, iritis, retinal detachment, retinal tear, transient or persistent glaucoma, vitritis, iris prolapse, secondary surgical intervention and increased visual symptoms related to the optical characteristics of the iol including halos, glare and/or double vision.The type of inflammation as well as onset and duration were not specified.Therefore, an exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Claim # (b)(4).
Additional Manufacturer Narrative
Device evaluation 3331 - device history record (dhr) review - the device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lens that would have caused or contributed to the nature of this complaint.Corrective and/or preventive actions are being addressed through capa-24-001 and this issue will continue to be tracked and trended as part of the normal device safety committee meetings and capa monitoring.Claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: 19105572
• Report Number: 2023826-2024-01731
• Device Sequence Number: 20786689
• Product Code: MTA
• UDI-Device Identifier: 00840311308101
• UDI-Public: 00840311308101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: VTICM5 12.6
• Device Catalogue Number: N/A
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 07/07/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• 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: Other
• Patient Sex: Unknown