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

Model Number	GCB00
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6b - explant date: not applicable, as lens remains implanted.Section e1 - telephone number: (b)(6).Section h3 - other (81): 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 after the intraocular lens (iol) insertion, the surgeon discovered that the haptics were sticking together and it was difficult to separate them.This was observed with a total of three (3) out of twelve (12) cases of the day.The physician prepared the iol according to the directions for use (dfu).Through follow-up we learned that the iols were stored according to the dfu.The unfolding of the lens required extra maneuvers and instruments that were used to push and separate the haptics apart.The patient is doing good.Patient conditions were not affected, except for a slight delay due to use of extra instruments.No further information was provided.This is report 3 of 3.A separate report is being submitted for each of the lenses involved.
Additional Manufacturer Narrative
Upon further review it was noted that event detail provided below was inadvertently omitted from the initial report.Therefore, the following fields have been updated accordingly: section b5 - describe event or problem: account indicated that the text of the preloaded intraocular lens (iol) packaging is hard to read compared to other iols in use.The surgeon took longer to see and ensure that it is the iol with the correct diopter needed.Section h6 -health effect - medical device problem code: 3191: dissatisfaction - quality/design.Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: no suspect product was received by the manufacturer; however, a photograph provided by the customer was evaluated.The picture shows an eye being implanted with a lens claimed to be a tecnis 1-piece iol with smartload delivery technology, model gcb00.The picture shows an iol in the intraocular space with the lens haptics attached (stuck) between them.The root cause or the potential clinical impact of the reported event cannot be determined from a picture assessment.Therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.The complaint issue of haptic stuck to haptic 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.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: 17909496
• Report Number: 3012236936-2023-02375
• Device Sequence Number: 7525686
• Product Code: HQL
• UDI-Device Identifier: 05050474620605
• UDI-Public: (01)05050474620605(17)260112
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 12/19/2023

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: GCB00
• Device Catalogue Number: GCB0000200
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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
• Patient Sex: Unknown