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

Model Number VICM5 13.7

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cataract (1766)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

Weight-race: unk.(b)(4).Lens work order search- no similar complaint event(s) within associated lots were found.Claim # (b)(4).

Event Description

The reporter indicated that a 13.7mm vicm5 13.7 implantable collamer lens of -8.50 diopter was implanted into the patients right eye (od) on (b)(6) 2022.On (b)(6) 2022 the lens was removed due to lens opacity (cataract); anterior subcapsular cataracts (asc).The problem was resolved.Patient had a cataract surgery with pseudophakic iol implantation.Cause reported as user error.

• 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14598784
• MDR Text Key: 293338976
• Report Number: 2023826-2022-01733
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2022

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 Model Number: VICM5 13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2022
• 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-TF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female