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

Model Number	GCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the lens was implanted the doctor saw a foreign body shaped like a ring.The foreign material was removed from the eye and the lens remains implanted.A delay in the procedure was mentioned; however, no medication or surgical intervention was required.No impact on daily activities reported and the patient has fully recovered.No further details were provided.
Additional Manufacturer Narrative
Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If explanted, give date: not applicable, the lens remains implanted.Initial reporter telephone number: (b)(6).The device was not returned for evaluation as it remains implanted.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.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that section "b3" was inadvertently not addressed in the section h10 of the initial mdr report; therefore, it has been addressed in this supplemental mdr report as indicated below: section b3 - date of event: date unknown/ not provided all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Section d9: returned to manufacturer on: 31 may 2022.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the alleged foreign material was received wrapped in gauze.Product evaluation was not performed because the lens remains implanted.The alleged foreign material was received and was evaluated.The product was forwarded to eag for further analysis.Per eag laboratories, energy dispersive x-ray (edx) analysis of the area of interest revealed the presence of ti, with lower levels of al and v.Smaller amounts of fe, na, mg, si, p, s, cl, ca and fe were also detected.This data suggests a ti-al-v alloy (e.G., ti-6al-4v, or ti64), likely with aluminosilicates (¿dirt¿) and salts.Ftir analysis could not be used to identify the foreign material and therefore the results could not be compared against the añasco manufacturing library.The complaint issue of foreign material was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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
• MDR Report Key: 14682567
• Report Number: 3012236936-2022-01428
• Device Sequence Number: 20186141
• Product Code: HQL
• UDI-Device Identifier: 05050474620735
• UDI-Public: (01)05050474620735(17)241208
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 12/08/2024
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 08/18/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 06/13/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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