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

Model Number	MICL 13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, -5.5 diopter, implantable collamer lens noticed to be torn before vial was opened on (b)(6) 2019.There was no patient contact.Back-up lens was implanted and problem resolved.Per the reporter on (b)(6) 2019, "upon opening the package, the surgeon noticed looking through the vial that the lens was torn.".
Additional Manufacturer Narrative
Additional information; device evaluation: lens was returned in vial, in liquid.Visual inspection found optic and haptic torn.Lens vial returned with vial seal removed.(b)(4).
Additional Manufacturer Narrative
Result code 114 should have been included in supplemental medwatch report.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: 8957661
• Report Number: 2023826-2019-01560
• Device Sequence Number: 13991149
• Product Code: MTA
• UDI-Device Identifier: 00841542103206
• UDI-Public: 00841542103206
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• 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: 09/04/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 11/13/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/11/2019; 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1