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

Model Number	MICL 13.2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reportedly, a 13.2mm, micl 13.2, -16.0 diopter, implantable collamer lens was "too long".The lens was removed and scheduled exchange of a shorter length lens.No patient injury.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
Product problem (e.G.Malfunction) is not applicable in original mdr; corrected to adverse event because lens was explanted.Claim#: (b)(4).
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
Malfunction reported in original mdr is not applicable; corrected to serious injury.Required intervention to prevent permanent impairment/damage (devices).Work order search: no similar complaint type events were reported for units within same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: device evaluation: lens returned dry taped to cartridge case.Visual inspection: lens haptic is bent with residue.No visible damage to sfc-45 cartridge.(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: 8631809
• Report Number: 2023826-2019-00845
• Device Sequence Number: 2354447
• Product Code: MTA
• UDI-Device Identifier: 00841542103411
• UDI-Public: 00841542103411
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• 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: 05/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 08/20/2019; 08/20/2019; 08/21/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/04/2019; 08/20/2019; 08/20/2019; 08/21/2019
• 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: 45 YR