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

Model Number	CC4204A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Posterior chamber single piece foldable intraocular lens.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 a cc4204a intraocular lens, diopter +20.0 tore during insertion into the patient's eye.This occurred on (b)(6) 2020.The lens was removed and replaced with an alternate lens.
Additional Manufacturer Narrative
B5-updated information: the reporter stated there was patient contact with the lens.Patient contact was also stated on the returned box.However, the lens was returned stuck in the cartridge.The reporter previously stated no additional information is available.Information is contradictory.H3-device evaluation: the lens was returned loose in the box, stuck in the cartridge.The plunger was overridden and there was residue on the device.Claim# (b)(4).
Additional Manufacturer Narrative
B1-corrected.B5-additional information: there was patient contact with the lens.No patient injury.H6-health impact code corrected.Device code corrected.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: 11159189
• Report Number: 2023826-2021-00114
• Device Sequence Number: 837133
• Product Code: HQL
• UDI-Device Identifier: 00841542102391
• UDI-Public: 00841542102391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 01/14/2021; 02/23/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/08/2021; 03/17/2021
• 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: INJECTION SYSTEM MODEL: NANOPOINT.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention