MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SMARTLOAD; INTRAOCULAR LENS

Model Number	GCB00
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or dob, weight, ethnicity: information unknown not provided.If explanted, give date: device remains implanted, therefore no explant date available.Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after implantation of the intraocular lens (iol) a short fiber was identified in the anterior chamber.The fiber was aspirated out during removal of ovd (healon gv pro).It was reported that there was no effect on the patient and no need for extra visits at this point.The patient's daily activities were not significantly affected by this issue and the patient has fully recovered.The product is not available for investigation.Additionally, it was noted that the fiber is not available, it was aspirated out of the eye and discarded.No further information was provided.

• Brand Name: SMARTLOAD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12669965
• Report Number: 2020664-2021-07780
• Device Sequence Number: 17557541
• Product Code: HQL
• UDI-Device Identifier: 05050474620728
• UDI-Public: (01)05050474620728(17)240527
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 05/27/2024
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/21/2021
• 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: HEALON GV PRO, LOT: UNKNOWN