MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: collamer® ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Device evaluation: returned product evaluation found no lens returned in box.Work order search: no similar claim type was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a cq2015, +20.5 diopter, collamer three piece intraocular lens ripped during the loading process because of the injector.The reporter stated that they discarded the lens and returned the empty box to the manufacturer.There was no patient contact.The nanopoint injector was used.
Additional Manufacturer Narrative
Device evaluation: a stuck or ripped iol may be caused by neglecting ovd application or by not applying ovd in a sufficient amount.The nanapoint cartridges are not coated and the gliding property is from the material itself.The added gms is emigrating to the surface of the inner lumen of the cartridge and ensures the gliding through the tip.It is highly requested that the end user is adding ovd in a sufficient amount.Another root cause might be the loading process.The end user may notice the same appearance as reported in this complaint in cases of pinched haptic or optic.(b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6642443
• Report Number: 2023826-2017-00969
• Device Sequence Number: 11008267
• Product Code: HQL
• UDI-Device Identifier: 00841542101998
• UDI-Public: 00841542101998
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: CQ2015A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1