MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: unk.Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned dry in a specimen cup.Visual inspection found a piece of one haptic torn off.There was residue and debris on the lens.No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
A cc4204a collamer single piece lens, +18.0 diopter, was received damaged.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
The reporter indicated the lens may have been damaged while the lens was advancing in the injector and the haptic got caught.And the surgeon requested another lens.There would have been no patient contact.No more information was available.Claim#: (b)(4).

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8143311
• Report Number: 2023826-2018-01820
• Device Sequence Number: 16194009
• Product Code: HQL
• UDI-Device Identifier: 00841542102353
• UDI-Public: 00841542102353
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 04/30/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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 AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Age: 65 YR