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

Model Number VTICM5 12.6

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

Patient Problem Inflammation (1932)

Event Type  Injury  

Event 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.

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).

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)
• Type of Device: 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
• MDR Text Key: 340156477
• Report Number: 2023826-2024-01731
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311308101
• UDI-Public: 00840311308101
• 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: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 07/07/2024
• Supplement Dates FDA Received: 07/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2023
• 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): Other