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

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Lens was returned in vial, in liquid.Visual inspection found optic and haptic torn.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that on (b)(6) 2019 a cc4204a, +19.0 diopter, intraocular lens was noticed to be torn after implanted into the patient's right (od) eye.During the initial surgery, the lens was removed and a back-up lens was implanted with no patient injury.This resolved the problem.Cause of the event is reported as unknown.
Additional Manufacturer Narrative
Device evaluation: nanopoint returned in lens box with clear surgical residue on product.Visual inspection found no visible damage to device and residue on cartridge.Lens stuck in cartridge.Claim#: (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: 8910115
• Report Number: 2023826-2019-01446
• Device Sequence Number: 205750
• Product Code: HQL
• UDI-Device Identifier: 00841542102377
• UDI-Public: 00841542102377
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 10/31/2020
• 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: 08/08/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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: NANOPOINT INJECTOR SYSTEM
• Patient Age: 71 YR