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

Model Number	MICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Visual Disturbances (2140); No Code Available (3191)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: secondary surgical intervention,explant.Work order search- no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm micl13.2 , -125 diopter was implanted and removed on (b)(6) 2018 due to high iop and unhappy vision.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Two similar complaint type event were reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Additional information: the reporter indicated that the lens was implanted into the patients left eye (os) on (b)(6) 2018.The lens was removed on (b)(6) 2018 due to excessive vault, pupil block with elevated iop (date assessed: (b)(6) 2018 and (b)(6) 2018), and unreactive pupil.Enlargement of pi (yag and surgical) was reported.On (b)(6) 2018 the lens was exchanged for a different diopter and shorter length lens.It was reported that this exchange resolved the problem.Additional information reported: patient had icl od without complications (b)(6) 2018.Patient had prk ou without complication (b)(6) 2018.Reporter stated that possible cause of event was ugh syndrome despite patent pi.(b)(4).
Additional Manufacturer Narrative
Corrected data: (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: 7835113
• Report Number: 2023826-2018-01317
• Device Sequence Number: 1964035
• Product Code: MTA
• UDI-Device Identifier: 00841542103343
• UDI-Public: 00841542103343
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/31/2018

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: 01/31/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/20/2018; 10/26/2018; 11/01/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/09/2018; 10/26/2018; 11/01/2018
• 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: 31 YR