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

Model Number	MICL13.7
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	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned dry, taped to a plastic container.Visual inspection found no visible damage to the lens.There was evidence of residue on the lens.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -15.5 diopter, in the patients left eye (os) on (b)(6) 2018.At one day post-op, the lens was trying to protrude through the pupil and was kinked (too big).The pupil would not constrict.The lens was explanted on (b)(6) 2018 but the pupil remained dilated.The incision was enlarged slightly to remove the lens and sutures were required.Another lens was not implanted.
Additional Manufacturer Narrative
Additional data: the reporter indicated at 1 day post-op, showed high central vault.The intraocular pressure (iop) was high for first few days, yet 1 day post-op, the eye was soft with flat anterior chamber.2 day post-op, iop 28mmhg.The surgeon felt the orbscan wtw may have been measured incorrectly.(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: 7954052
• Report Number: 2023826-2018-01504
• Device Sequence Number: 19120298
• Product Code: MTA
• UDI-Device Identifier: 00841542103671
• UDI-Public: 00841542103671
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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): 09/10/2018

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: 08/31/2019
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/02/2018
• 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: 29 YR