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 Code	No Patient Involvement (2645)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the lens was returned stuck in the cartridge and in the lens case.There was clear surgical residue on the cartridge.Visual inspection found no visible damage to the device.Lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that as the surgeon was loading a 13.2mm tmicl13.2 implantable collamer lens, -12.0/+4.0/070 (sphere/cylinder/axis) it tore.This occurred on (b)(6) 2019 and there was no patient contact with this lens.A back up lens was then used.The surgeon does not know the cause of the event.
Additional Manufacturer Narrative
Corrected to (b)(6) 2019 in initial mdr.Corrected to (b)(6) 2019 in initial mdr.Corrected to device evaluation: the lens was returned stuck in the cartridge.Visual inspection of the lens found the lens returned in the cartridge.The cartridge was returned in the lens case with clear surgical residue.Visual inspection of the cartridge found no visible damage and residue on the cartridge.(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: 8692893
• Report Number: 2023826-2019-01062
• Device Sequence Number: 19326654
• Product Code: QCB
• UDI-Device Identifier: 00841542109352
• UDI-Public: 00841542109352
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/15/2019

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: 10/31/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL/LOT#-UNK; INJECTOR MODEL/LOT#-UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL/LOT#-UNK; INJECTOR MODEL/LOT#-UNK
• Patient Age: 33 YR