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

Model Number VTICM5_12.6

Device Problem Misfocusing (1401)

Patient Problem Blurred Vision (2137)

Event Date 08/11/2021

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -5.0/+2.0/005 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2021.On (b)(6) 2021 the lens was exchanged with a same size, different sphere/cylinder/axis lens due to refractive surprise.The problem is resolved.

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No similar complaint type events reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

H3: device evaluation: the lens was returned dry in a micro-centrifuge vial.Visual inspection found that the haptic was broken.Dimensional inspection found the lens to be within specification.Functional inspection found the returned lens did not meet original values measured at the time of manufacturing.H6-investigation code 3331: device history record (dhr) review-based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 13122738
• MDR Text Key: 285360457
• Report Number: 2023826-2021-05007
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• 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
• Report Date: 12/09/2021

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: 12/31/2023
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• 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: 31 YR
• Patient Sex: Female