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 Patient Involvement (2645)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned in liquid, in lens vial, with residue on lens.Visual inspection found one haptic torn.A cartridge was returned and there was no visible damage to the device.Another similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated a 13.2mm tmicl13.2 implantable collamer lens, - 8.50/+2.5/087 (sphere/cylinder/axis), tore during the loading process, while being inserted into the cartridge.There was no patient contact.The backup lens was implanted and the problem was resolved.The cause of the event was unknown.
Additional Manufacturer Narrative
Device evaluation: the statement is corrected to; " lens returned in liquid in a lens vial.Visual inspection found haptic torn.Cartridge returned in lens box with clear surgical residue on product.Visual inspection found no visible damage to device and residue on cartridge.(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: 8962472
• Report Number: 2023826-2019-01586
• Device Sequence Number: 19450656
• Product Code: QCB
• UDI-Device Identifier: 00841542108836
• UDI-Public: 00841542108836
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• 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: 08/29/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 11/01/2019
• 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 # 1430617; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL AND LOT # UNK