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

Model Number	MICL 13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Patient Problem/Medical Problem (2688); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.Patient code:(b)(4) secondary surgical intervention, exchanged, angle closure.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm micl13.2, -10.5 diopter , implantable collamer lens and resulted in a very high vault , angle closure with elevated iop (intraocular pressure) was also observed.The lens was exchanged for a shorter length lens.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
Corrected data: (b)(4).
Additional Manufacturer Narrative
Corrected data: correct patient identifier is (b)(6) not (b)(6).Complaint is an adverse event; secondary surgery was performed to exchange lens.Therefore, product problem is incorrect.Claim # (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: 7583196
• Report Number: 2023826-2018-00869
• Device Sequence Number: 2514639
• Product Code: MTA
• UDI-Device Identifier: 00841542103305
• UDI-Public: 00841542103305
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: MICL 13.2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 08/08/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 08/01/2018; 08/08/2018
• 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