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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -4.5 diopter, into the patient's left (os) eye on (b)(6) 2020.On the same date, in a separate surgery, the surgeon exchanged the lens with a shorter lens due to excessive vault and elevated iop.The problem was resolved.The cause of the event is reported as device "(size).".
Additional Manufacturer Narrative
Additional information: h3-device evaluation: lens returned in liquid in lens case/ vial.Visual inspection found haptic torn.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
• MDR Report Key: 9910966
• Report Number: 2023826-2020-00675
• Device Sequence Number: 3435801
• Product Code: MTA
• UDI-Device Identifier: 00841542103183
• UDI-Public: 00841542103183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 10/31/2021
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR