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

Device Problems Misfocusing (1401); Optical Problem (3001)

Patient Problems Vitreous Floaters (1866); Intraocular Pressure Increased (1937); Pain (1994); Retinal Detachment (2047); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient reported the surgeon implanted an icl implantable collamer lens in her left eye (os), on (b)(6) 2023.On (b)(6) 2023, the patient had sudden and painless loss of vision.The patient went to hospital and was treated for high intraocular pressure.On (b)(6) 2023 the surgeon performed laser peripheral iridotomies (lpi).The patient reported reduced visual acuity, permanent dysphotopsias, glare/halo, significant refractive error and pain.The reporter indicated the cause of the event was due to the laser peripheral iridotomies (lpi) the surgeon had performed post-op.Post-op the patient had retinal detachments and floaters.The lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A4: unk a5: unk a6: unk b3:unk d4: expiration date unk d6b: unk e3: unk h4: unk h6: health impact- clinical code: 4581 - reduced va, dysphotopsias, refractive error h6: health impact - additional surgery: 4625 - addition of laser peripheral iridotomy (lpi) claim #(b)(4).

Manufacturer Narrative

Corrected data: h10 - disregard all supplemental mdr #1 information as it was submitted in error.Claim#:(b)(4).

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial, dry with residue/debris on product.Visual inspection foudn no visble damage to the lens.Dimensional inspection found the lens within specifications.Claim#: (b)(4).

Manufacturer Narrative

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: 17372841
• MDR Text Key: 319522574
• Report Number: 2023826-2023-03028
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/28/2023; 10/12/2023; 10/23/2023
• Supplement Dates FDA Received: 10/09/2023; 10/13/2023; 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female