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

Model Number GIB00

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: date unknown/ not provided.Serial#: unknown/ not provided catalogue#: a complete catalog # is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi #: unknown as product serial number was not provided.If implanted; give date: not applicable.The lens was inserted and removed during the same procedure.If explanted; give date: not applicable.The lens was inserted and removed during the same procedure.(b)(6).Initial reporter: email address: unknown/ not provided.The intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Device manufacture date: unknown as product serial number was not provided.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens was cracked during implantation and the gib00 cartridges are running more stiff than before.The lens had to be removed again.This occurred often lately and the customer is unhappy about this.No further details were provided.This report is for the unknown number of incidents without serial or exact model numbers provided.A separate report will be submitted for the single incident with lens serial number provided.

Manufacturer Narrative

Additional information: this supplemental filing is to update the following fields per additional information received: section b5 - describe event or problem: through follow-up we learned that a new intraocular lens has been implanted in the patients eye during the procedure and the material is not available for investigation.No further details were provided.Section h6 -health effect - impact code: 4631 - more complex surgery all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15460026
• MDR Text Key: 306360899
• Report Number: 3012236936-2022-02368
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIB00
• Device Catalogue Number: GIB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1