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

Model Number VICMO12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Glaucoma (1875); Intraocular Pressure Increased (1937); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, -18.00 diopter, into the patients right eye (od) on(b)(6)2022.The lens was reported as low vaulting and remained implanted.This was the replacement lens for mfr.Report # 2023826-2023-00265.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Additional data: h6: health impact - additional surgery: 4625 - enlarge peripheral iridotomy.Corrected data: b5: the reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, -18.00 diopter, into the patients right eye (od) on (b)(6) 2022.The lens was explanted on (b)(6) 2022 due to elevated intraocular pressure and glaucoma.An iridotomy was performed but the tension did not go down.The patient had a cataract lens implanted and the problem was resolved.This was the replacement lens for mfr.Report # 2023826-2023-00265.The cause of the event was due to user error and the device did not fail to perform as intended.H6: medical device code: 2993.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
• MDR Report Key: 16326950
• MDR Text Key: 309166625
• Report Number: 2023826-2023-00266
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2022
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female