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

Model Number VICMO12.1

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

Patient Problems Headache (1880); Pain (1994); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/08/2021

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens, -07.00 diopter, in the patients left eye (os), on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to patient complained of eye distension, eye pain, dizziness and headache.The problem was resolved.The cause of the event was unknown.

Manufacturer Narrative

Weight: unk.Race: unk.Ethnicity: unk.Pma/510k: this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Claim # (b)(4).

Manufacturer Narrative

Weight: unk.Race: unk.Ethnicity: unk.Pma/510k: this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens, -07.00 diopter, in the patients left eye (os), on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to patient complained of eye distension, eye pain, dizziness and headache.The problem was resolved.The cause of the event was unknown.

• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13057261
• MDR Text Key: 286067707
• Report Number: 2023826-2021-04915
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 11/22/2021

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 Expiration Date: 09/30/2023
• Device Model Number: VICMO12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2020
• 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 MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female