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

Model Number MICL13.2

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intraocular Pressure Increased (1937); Nausea (1970); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/16/2021

Event Type  Injury  

Manufacturer Narrative

Weight: unk, ethnicity: unk, race: unk.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -10.00 diopter, in the patients left eye (os) on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to angle closure and elevated intraocular pressure (iop).The surgeon enlarged the pis.The patient complained of eye pain and nausea.Another lens was not implanted.Patient was taking kratom or possibly other meds/drugs, pt admitted to using "edible" cbd gummy and kratom.

Manufacturer Narrative

H3: device evaluation: the lens was returned in liquid, in a contact lens case.Visual inspection found a haptic torn.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
• MDR Report Key: 12005327
• MDR Text Key: 261013268
• Report Number: 2023826-2021-01927
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00084154210329
• UDI-Public: 0084154210329
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

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: 12/31/2022
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR