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); Missing Value Reason (3192)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Lens was returned dry, in a specimen container.Visual inspection found a torn haptic and residue on the lens surface.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm, micl13.2, -14.0 diopter, implantable collamer lens into the patients right eye (od) on (b)(6) 2018.The lens was exchanged on (b)(6) 2018 with a shorter length lens due to pupil block with elevated iop (intraocular pressure), too large lens with ac shallowing, high vaulting and narrowing of angle.This exchange resolved the problem.
Additional Manufacturer Narrative
(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: 7875111
• Report Number: 2023826-2018-01395
• Device Sequence Number: 2488986
• Product Code: MTA
• UDI-Device Identifier: 00841542103374
• UDI-Public: 00841542103374
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: MTA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: 07/31/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/30/2018
• 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: 36 YR