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

Model Number	GAB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Explant date: not applicable, lens remains implanted.Telephone number: (b)(6).The intraocular lens (iol) was not returned for evaluation as it remains implanted.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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that upon implantation, an intraocular lens (iol) showed a mark at the edge of the optic.Through follow-up we learned that the iol remains implanted and no interventions were required or planned.No further information was provided.
Additional Manufacturer Narrative
Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: the photographs provided by the customer were evaluated.The provided photographs display a pseudophakic eye implanted with a lens claiming to be a sensar 1pc.A discontinuity can be observed on the posterior side of the lens edge.The root cause of the reported event cannot be determined from a picture assessment.The potential clinical impact of the reported issue may require to correlate it to a patient clinical assessment.The complaint issue provided as cosmetic issues could not be confirmed.However, the observed issue of lens damaged is similar to the complaint issue reported by the customer.However, it could not be confirmed to be related to the manufacturing or design process.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 ; 7142478552
• MDR Report Key: 16595394
• Report Number: 3012236936-2023-00657
• Device Sequence Number: 14559567
• Product Code: HQL
• UDI-Device Identifier: 05050474621756
• UDI-Public: (01)05050474621756(17)260112
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 04/18/2023

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: 01/12/2026
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000185
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VITAN UNFOLDER
• Patient Sex: Unknown