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

Model Number	MICL12.6
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	06/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned dry in cartridge tray.Visual inspection found a torn haptic and foreign material on the surface of the lens.(b)(4).
Event or Problem Description
The surgeon indicated that a12.6mm micl12.6, -9.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was removed and exchanged for a shorter length lens due to observation of excessive vault.This exchange resolved the problem.
Additional Manufacturer Narrative
Additional information: angle closure.Work order search: no similar complaint type events were reported for units within the same lot.Corrected data: on (b)(6) 2018 the lens was explanted for a shorter lens due to excessive vaulting and angle closure with elevated iop.Another lens was implanted on the same day.On the patient's last visit on (b)(6) 2018, the status of the eye was comfortable with poor pupil constriction and minimal halo and glare.(lens exchange) to (lens explant) - previous code is not applicable, lens was explanted.(b)(4).
Additional Manufacturer Narrative
Additional information: the vault was improved, but it was still high.Iop (intraocular pressure) is wnl (within normal limits).It is believed that the high iop (intraocular pressure) from pupilary block caused the constriction issue.Pupil constriction and glare improved but are still present.(b)(4).

• Brand Name: MICL
• Common Device Name: IMPLANTABLE COLLAMER LENS (ICL)
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7683601
• Report Number: 2023826-2018-01019
• Device Sequence Number: 1316239
• Product Code: MTA
• UDI-Device Identifier: 00841542103008
• UDI-Public: 00841542103008
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 06/13/2018

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: 09/30/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 09/17/2018; 09/25/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/17/2018; 10/09/2018
• 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: 30 YR