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

Model Number	TMICL13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One similar complaint type event was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that 13.2mm, tmicl13.2, -10.00/1.0/107 (sphere/cylinder axis) implantable collamer lens tore during loading into injector.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: b5- "the reporter indicated that a 13.2mm tmicl 13.2, -10.00/1.0/107 (sphere/cylinder/axis) implantable collamer lens tore during loading into the injector for the left eye (os) on (b)(6) 2019.There was no patient contact.A replacement lens was implanted and the problem was resolved.The cause of the event is reported as due to loading error." should be in the initial mdr.H3- device evaluation: "liwuid" should be corrected to "liquid" in the previous mdr.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned in liwuid in a lens case/vial.Visual inspection found the haptic torn.Claim#(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9563657
• Report Number: 2023826-2020-00059
• Device Sequence Number: 16700401
• Product Code: QCB
• UDI-Device Identifier: 00841542109017
• UDI-Public: 00841542109017
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2019

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: 09/30/2020
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 04/07/2020; 08/07/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 05/08/2020; 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR