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

Model Number	PCB00
Medical Device Problem Codes	Use of Device Problem (1670); Mechanical Jam (2983); Ejection Problem (4009)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the monofocal intraocular lens (iol) was not ejecting.The surgeon and tech claim that the lens got stuck when injecting.The doctor used extra force (more pressure) on plunger and lens came out forcefully and broke capsule.The surgery was finished using a non-johnson & johnson lens of 18.5 diopter.The affected eye was the right eye and there was patient contact.There were no medical or surgical interventions reported.The account noted it is unknown if the problem related to use error.It is unknown if the patient had a capsule tear and the patient outcome status is unknown.No further information was provided.
Additional Manufacturer Narrative
Section a4, a5, a6: unknown/ not provided.Asku.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search of complaints related to this production order was performed in the system.The search revealed one complaint folder.The complaint issues reported are not related.Based on complaint handling report results, no further actions are required.Conclusion: as a result of the investigation, the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 19662280
• Report Number: 3012236936-2024-000186
• Device Sequence Number: 6596257
• Product Code: HQL
• UDI-Device Identifier: 05050474558274
• UDI-Public: (01)05050474558274(17)251003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2025
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• 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: 06/17/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female