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

Model Number VICM5_12.1

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

H6 - 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 12.1mm vicm5_12.1 implantable collamer lens, -14.00 diopter, into the patient's right eye (od) on (b)(6) 2023.The lens was explanted on (b)(6) 2024 due to patient experienced a refractive surprise.The lens was replaced with a same length but different model/power lens and the problem was resolved.

Manufacturer Narrative

H3: device evaluation: the lens was returned dry, in a microcentrifuge vial, with residue/debris on product.Visual inspection found the lens haptic broken and stretched out.Dimensional verification was performed and the lens was found to be in specification.Refractive verification was performed and the returned lens did not meet original values measured at the time of manufacturing.Claim # (b)(4).

Manufacturer Narrative

H6: device history record (dhr) review: the dhr review indicated that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.(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 ; 6263037902
• MDR Report Key: 19217934
• MDR Text Key: 341457105
• Report Number: 2023826-2024-01911
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300358
• UDI-Public: 00840311300358
• 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,Followup
• Report Date: 04/04/2024

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_12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 06/18/2024; 08/23/2024
• Supplement Dates FDA Received: 07/12/2024; 08/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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: 28 YR
• Patient Sex: Female