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

Model Number VICM5 12.6

Device Problem Misfocusing (1401)

Patient Problem Blurred Vision (2137)

Event Date 09/02/2023

Event Type  Injury  

Manufacturer Narrative

H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated that a 12.6mm, vicm5_12.6, -3.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2023.On (b)(6) 2023 the lens was replaced with a same size , different diopter toric lens due to refractive surprise.The problem was resolved.

Manufacturer Narrative

H3: device evaluation: the lens was returned in a microcentrifuge vial with moisture and residue/debris on the product.Visual inspection found the optic torn and haptic broken.Dimensional inspection found the lens to be within specifications.Functional inspection found the lens did not meet original values measured at the time of manufacturing.H6: type of investigation 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 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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18788736
• MDR Text Key: 336339010
• Report Number: 2023826-2024-00752
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 02/06/2024

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 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/31/2024
• Supplement Dates FDA Received: 04/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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: 19 YR
• Patient Sex: Female