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

Model Number	GAB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: information unknown/ not provided.Implant date: does not apply - lens was not implanted.Explant date: does not apply - lens was not implanted and therefore not explanted.Reporter telephone number: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that one of the haptic of an intraocular lens (iol) was defective.The customer noticed a small fracture while the lens was still in the shooter.According to the customer, there was no contact with the patient's eye.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device evaluation: the preloaded product was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.A search revealed that no additional/similar (as applicable) complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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? yes.Section d9 - date returned to manufacturer: 23th february 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the complaint lens and smartload were received in the smartload insert.Visual inspection under magnification revealed that the lens was received stuck to the smartload insert.The lens was removed and cleaned, presenting with no issues.The received smartload was also inspected, presenting with no issues.The complaint issue could not be confirmed and, no product deficiency could be identified.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.The reported issue is an anticipated/expected event for gab00 (smartload sensar 1 piece) and does not represent a new risk.Based on the last annual risk management review and ongoing post market surveillance activities, the probability of occurrence for the reported event remains within the risk management files.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12643788
• Report Number: 2020664-2021-07728
• Device Sequence Number: 14583428
• Product Code: HQL
• UDI-Device Identifier: 05050474621848
• UDI-Public: (01)05050474621848(17)231029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2022

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: 10/29/2023
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/28/2021; 03/14/2022
• Initial Report FDA Received Date: 10/16/2021
• Supplement Report FDA Received Date: 11/22/2021; 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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