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

Model Number	CQ2015A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sex, weight, ethnicity, race: unk.Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens the lens and associated cartridge were returned dry, in a ziploc bag.There was clear surgical residue on the lens and cartridge.Visual inspection found no visible damage to the lens or cartridge.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that prior to injecting a cq2015a intraocular lens, diopter +18.5, the haptic was noted to be bent.Reportedly, there was no patient contact with the lens.The cause of the event is reported as unknown.
Additional Manufacturer Narrative
Concomitant medical products - cartridge model-sfc-45; lot#-unk should be corrected to cartridge model-cq; lot#-unk in initial medwatch report.(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: 9221390
• Report Number: 2023826-2019-01966
• Device Sequence Number: 11302217
• Product Code: HQL
• UDI-Device Identifier: 00841542101950
• UDI-Public: 00841542101950
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• 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): 09/26/2019

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: 08/31/2020
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/27/2019
• 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-CQ, LOT#-UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK
• Patient Age: 67 YR