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

Model Number	MICL 13.2
Medical Device Problem Codes	Material Opacification (1426); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cataract (1766); Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	06/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned in liquid, in a specimen cup.Visual inspection found no visible damage to lens.(b)(4).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, -8.0 diopter, implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2019."due to floppy iris and high pressure resulting in angle closure", the lens was removed on (b)(6) 2019.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Device code: 1426, should be removed from supplemental #2 as it is not applicable.Claim#: (b)(4).
Additional Manufacturer Narrative
Device code: 1426 should have been added in supplemental medwatch report.Work order search: "no similar complaints" should be corrected to "three similar complaints." result code: 213 should be corrected to 114.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information :the reporter indicated that excessive vault (initially 1.5, then changed to 5) was observed.Pupil block with elevated iop (55 mmhg) and angle closure with elevated iop (55 mmhg) were observed on (b)(6) 2019, lens opacity (asc) observed on (b)(6) 2019.Reportedly enlargement of pi and addition of new pi were surgically performed.Cause of the event is reported as unknown and "topomax related shift? surgically enlarged pi failed to resolve edematuous cb worsened by topomax?" per reporter on (b)(6) 2019, "there is cataract formation and patient is scheduled for ce with iol implantation." (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: 8772247
• Report Number: 2023826-2019-01176
• Device Sequence Number: 1707908
• Product Code: MTA
• UDI-Device Identifier: 00841542103251
• UDI-Public: 00841542103251
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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): 06/10/2019

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: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019; 09/10/2019; 09/16/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/23/2019; 09/11/2019; 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL#SFC-45, LOT#1438423; FOAMTIPPLUNGER MODEL#FTP, LOT#1378920; INJECTOR MODEL#UNK, LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR