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

Catalog Number N/A

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

Patient Problems Endophthalmitis (1835); Inflammation (1932); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Type  Injury  

Manufacturer Narrative

A review of the device labeling was completed.Iris adhesions, fibrin precipitation, vitreous opacity and endophthalmitis are identified in the labeling as potential adverse events from icl implantation.Per the dfu some adverse events may require secondary surgery.Under precaution the dfu states: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.The dfu under important basic notes states: (4) prior to surgery, thoroughly explain the expected effects, adverse events, future risks, etc.Associated with the use of this product to the patient who will be inserted with this product.Lens was not returned to date and there was no confirmation that any microorganism was identified.Claim#: (b)(4).

Event Description

The reporter indicated that an visian implantable collamer lens with centraflow technology was implanted into the patient's eye on an unknown date.The lens was implanted at a different medical institution than the one reporting this case.It is reported, inflammation was noted and the anterior chamber was "rinsed twice".It is noted that toxic anterior segment syndrome (tass) and/or endophthalmitis was suspected."posterior corneal deposits (kp), vitreous opacity, strong fibrin adhesion to the lens surface" was reported.On (b)(6) 2024 the patient visited the reporting medical institution where measures to explant the lens were taken and anterior chamber lavage with antibiotics was performed.The reporter states lens removal was difficult.Diagnostic culture and pcr testing of samples were performed and the lens was sent as well.No inflammatory organisms were detected.According to the pmda report submitted, investigation on (b)(6) 2024 found the patients inflammation had subsided and the visual acuity was corrected to 1.5 and unaided visual acuity to 0.06.The patient's vitreous opacity subsided and the patient outcome was stable and under monitoring in the reporter's opinion the cause is unknown.If additional information is received a supplemental medwatch report will be submitted.

• 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
• MDR Report Key: 18804571
• MDR Text Key: 336509184
• Report Number: 2023826-2024-00810
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

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 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: 01/29/2024
• Initial Date FDA Received: 02/28/2024
• 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): Required Intervention