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

Model Number	MICL12.1
Medical Device Problem Codes	Positioning Failure (1158); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned in liquid, in lens vial.Visual inspection found no visible damage to the lens.A lens work order search was performed.No similar complaint type events found.(b)(4).
Event or Problem Description
The reporter stated that a 12.1mm, micl12.1, -12.5 diopter, implantable collamer lens was implanted in the patient's left eye (os) upside down, the lens was removed and the backup lens was used.The reporter stated that there was no patient injury.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Corrected information: date of event was changed to (b)(6) 2018 previous reported date was incorrect.(b)(4).The lens was not implanted upside down as initially reported.The lens was implanted on (b)(6)) 2018 and exchanged on (b)(6) 2018 due to observation of low vault, elevated iop (intraocular pressure) without pupil block and significant reduction of irido-corneal angles.The reporter stated that the cause of event was due to patient related factor.(b)(4).
Additional Manufacturer Narrative
-implantable collamer lens was implanted in the patient's right eye (od).(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: 7648241
• Report Number: 2023826-2018-00973
• Device Sequence Number: 10794515
• Product Code: MTA
• UDI-Device Identifier: 00841542102803
• UDI-Public: 00841542102803
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/29/2018

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: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 07/02/2018; 09/10/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/01/2018; 09/10/2018
• 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: 24 YR