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

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: lens vial returned empty.No liquid or lens.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 cc4204a, +22.0 diopter, collamer single 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
Product returned in a plastic bag.Lens was returned stuck in cartridge.Visual inspection found no visible damage to device and lens stuck in cartridge.No visible damage to cartridge or injector.(b)(4).
Additional Manufacturer Narrative
Device evaluation: a visual inspection and a performance test were run with the present injector and cartridge.A hydrophobic iol was successfully injected under worst case scenario.This led to the conclusion that the iol was misloaded or a haptic has got pinched.The visual inspection pointed out that the trailing plate of the iol is torn.Most likely the trialing plate was pinched and therefore the iol got stuck.Method: process evaluation: device history record review found associated injector lot was manufactured within established parameters and limits.Corrected data: the lens was returned stuck in a cartridge inside a plastic bag.The lot number of the nanopoint injection system was provided.(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: 6635705
• Report Number: 2023826-2017-00968
• Device Sequence Number: 10913159
• Product Code: HQL
• UDI-Device Identifier: 00841542102438
• UDI-Public: 00841542102438
• 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,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: 11/30/2018
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: Not provided; 06/27/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 06/13/2017; 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR