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

Model Number	MICL12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect clinical code: (b)(4) significant reduction of irido-corneal angles, retained ocucoat, shallow ac.Health effect impact code: (b)(4) enlargement of pi (surgical), burped paracentesis, claim#: (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6; -11.0 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2021.The patient experienced excessive vaulting; elevated iop; significant reduction of irido-corneal angles; retained viscoatelastic/ocucoat; and enlargement of pi (surgical) was performed along with paracentesis to reduce iop.On (b)(6) 2021 the lens was explanted and later the same day replaced with a shorter length lens.It was noted postoperatively the patient had shallow ac 1000mm vault but indicated the problem was resolved and "patient's vault has slowly decreased to acceptable level with decreasing iop".The cause of the event was reported as a patient related factor and noted "retained viselastic in small eye & thick brown iris".
Additional Manufacturer Narrative
Corrected data: b5 - (b)(6) 2021 should be corrected to (b)(6) 2021.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 12271376
• Report Number: 2023826-2021-03057
• Device Sequence Number: 11888974
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: 00841542103046
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR