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

Model Number	CC4204A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).Device evaluation: lens was returned in vial, in liquid.Visual inspection found haptic torn.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the incision was noted to be too small for the +20.5 lens, cc4204a +20.5 diopter, intraocular lens to be injected.The surgeon tried pulling the lens out, the lens ripped.A new lens was obtained and implanted without problems.This was all during the same surgery and patient did not have any adverse effects from surgery.Enlargement of incision was reported.
Additional Manufacturer Narrative
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: 8025882
• Report Number: 2023826-2018-01586
• Device Sequence Number: 1352470
• Product Code: HQL
• UDI-Device Identifier: 00841542102407
• UDI-Public: 00841542102407
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: Health Professional
• Device Expiration Date: 07/31/2020
• 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: 10/25/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention