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

Model Number GIB00

Device Problem Crack (1135)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

Age, weight, ethnicity: information unknown/ not provided.Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.First name/last name: unknown/not provided.Email address: unknown/not provided.Initial reporter telephone number: (b)(6).The device was 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.Attempts were made to obtain the missing information as well as additional information regarding the complaint; however, to date, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the smartload intraocular lens (iol) device was faulty.Through follow up we learned that it is not clear if there was patient contact or not.Account indicated that the cartridge split at the tip during implantation.There was no harm to the patient and the lens was not implanted.No further information was provided.

Manufacturer Narrative

Section d9: device available for evaluation: yes section d9: returned to manufacturer on: 4 jan, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint smartload was received inside of the original smartload tray.The original lens was received loose inside of the original folding carton.Visual inspection under magnification revealed that the complaint smartload was received with the cartridge tip and cartridge cracked.The smartload assembly was inspected and no issues that could contribute to or cause the observed issues could be identified.Visual inspection under magnification revealed no issues with the lens.The complaint issue of cartridge tip cracked/damaged 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.Section h6: component codes; 4742 (inserter) 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: 15992203
• MDR Text Key: 308271991
• Report Number: 3012236936-2022-03061
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474654815
• UDI-Public: (01)05050474654815(17)250623
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• 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: GIB00I0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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