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

Model Number	GAB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when implanting the intraocular lens (iol) into the left eye, a piece of material (possibly a particle/piece from the cutting process) came out.The foreign material was removed from the patient's eye as soon as it was detected by manipulating the iol's surface with viscoelastic to separate it from the anterior face of the lens.There was an increase in the surgical time and intraocular manipulation, with no foreseen consequences for the patient.The lens remains implanted and the patient has fully recovered.No further information is available.
Additional Manufacturer Narrative
Pt.Info.: per eu regulation 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If explanted, give date: n/a (not applicable).The lens remains implanted.(b)(6).The intraocular lens (iol) and particle have not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, 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.

• 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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13582146
• Report Number: 3012236936-2022-00452
• Device Sequence Number: 19937700
• Product Code: HQL
• UDI-Device Identifier: 05050474621749
• UDI-Public: (01)05050474621749(17)240923
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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: 09/23/2024
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown