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 Code Available (3191)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens device evaluation: returned product evaluation found lens was returned in liquid, in a lens vial.Visual inspection found one haptic torn, missing piece of one haptic and clear residue on lens.(b)(4).Work order search: no similar claims were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a cc4204a, +22.0 diopter, single piece collamer lens tore during insertion into the patient's right eye.The lens was removed and replaced with the backup lens.There was an enlargement of the incision and no sutures were used.The reporter stated the nanopoint injection system was used.
Additional Manufacturer Narrative
Sdevice evaluation: conclusion - the root cause maight be a pinched haptic.This can be rooted by the loading process of the iol into the cartridge.Before closing the user has to ensure the right positioning of the optic and check that the haptics are positioned underneath the folding-support of the loading chamber.The position has to be controlled during the closing procedure by help of a sterile forceps.(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: 6573221
• Report Number: 2023826-2017-00709
• Device Sequence Number: 624709
• Product Code: HQL
• UDI-Device Identifier: 00841542102438
• UDI-Public: (01)00841542102438(17)181130
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 05/19/2017
• 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: NANOPOINT INJECTION SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 95