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

Model Number VTICM5 12.6

Device Problems Off-Label Use (1494); Unintended Movement (3026)

Patient Problems Inflammation (1932); Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

Expiration date: 30-apr-2025, clinical signs code (b)(4) - narrow angles; iris elevated.Investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -7.50/2.0/078 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.Narrow angles and iris elevated reported due to lens implanted upside down.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

B2-required intervention to prevent permanent impairment/damage (devices) b5-the reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -7.50/2.0/078 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.The lens was implanted upside down.On (b)(6) 2022 the lens was removed and the same lens was re-implanted in the correct orientation.After the lens was re-implanted;.Subsequently, iop increased, inflammation-like reaction, mydriasis.Significant reduction of iridocorneal angles.Pupil block with elevated iop not measurable.Angle closure with elevated iop not measurable.Anterior chamber contents present, 8/6 iop difficult to measure.The status of the patient's eye was reported as " on august 6, iop rose (unmeasurable) and anterior chamber contents appeared, so the anterior chamber was rinsed.With eye drops and oral medication, the iop decreased to 10 on (b)(6), but there was residual content, poor pupil shape, and corneal edema.Steroid eye drops were continued and the patient's symptoms improved.Currently, she continues to use steroids and pilocarpine in the left eye.Pupil shape has improved, but the left eye tends to contract, and there is currently a difference in pupil diameter between the left and right eyes.The problem was resolved.Cause is user error; and device did not fail to perform as intended.D6b- (b)(6) 2022.H6- clinical code: 4581: significant reduction of iridocorneal angles.Angle closure.Anterior chamber contents present.Poor pupil shape.Device code 1494: off-label use (under 21yrs of age at date of implant).Claim# (b)(4).

Manufacturer Narrative

B5 - corrected to: "the reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -7.50/2.0/078 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022." d6a - corrected to: implant date (b)(6) 2022.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15336964
• MDR Text Key: 299146759
• Report Number: 2023826-2022-02893
• Device Sequence Number: 1
• Product Code: QCB
• 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,Followup,Followup
• Report Date: 08/02/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICM5 12.6
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 09/06/2022; 10/10/2022
• Supplement Dates FDA Received: 09/07/2022; 10/10/2022
• Date Device Manufactured: 05/17/2022
• 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: CARTRIDGE MODEL: SFC-45: LOT# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male