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

Model Number	TMICL13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned still inside the cartridge, inside the lens box.Visual inspection found clear surgical residue on the lens.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
On (b)(6) 2019 a 13.2mm tmicl13.2 implantable collamer lens, -16.0/+1.0/074 (sphere/cylinder/axis) was returned to staar surgical.It was returned still inside of the lens cartridge and the box had "residue on lens" written on it.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Event updated information: on 06-sep-2019 it was discovered that this event is not mdr-reportable.However, the event had already been reported.Reporter states that the surgeon believes the forceps used to grasp the lens had rust on them.The surgeon then did not want to risk using the lens.No patient contact occurred.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8966509
• Report Number: 2023826-2019-01628
• Device Sequence Number: 2520555
• Product Code: QCB
• UDI-Device Identifier: 00841542109857
• UDI-Public: 00841542109857
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1