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

Catalog Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); Pupillary Block (2026); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

An article titled "a new ophthalmological application of nd:yag laser: reopening of the occluded central hole of visian implantable collamer lens in the treatment of acute angle - closure glaucoma indicated an implantable collamer lens was implanted into the patient's left eye (os).The patient complained of ocular pain 4 hours after implantation.It was then noted the patient experienced elevated iop (40mmhg) and the pupil was mid-dilated/pupil block.Medication was then prescribed.A following 2 hours the patient started vomiting with increased severity of pain along with increased iop; anterior chamber shallowing, high vaulting of icl and deposition of fibrinoid material was noted within the central hole of the icl which was seen in the slit-lamp examination.Fibrin deposit degradation was performed with yag laser along with additional medication was used as treatment for the icl central hole occlusion.The article concludes that the case demonstrates that nd:yag laser approach in the reopening of the occluded central hole with fibrin is an efficient safe and practical intervention in the treatment of cases with the central hole occlusion of evo visian icl's.Lens remains implanted.

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.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 enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 14108111
• MDR Text Key: 289286721
• Report Number: 2023826-2022-01206
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 03/21/2022

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: 03/21/2022
• Initial Date FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 23 YR
• Patient Sex: Female