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

Model Number	DCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a6: unknown; information not provided.Section d6b: if explanted, give date: the lens was implanted partially only.  section e1: telephone number: (b)(6).No zip code available.Device evaluation: product was received and evaluated.Visual inspection under magnification reveal the handpiece was received with the plunger rod partially advanced and overriding the lens which was stuck inside the cartridge; the plunger rod punctured through the cartridge.The cartridge and cartridge tip was bent and damaged; stress marks were observed where the lens was stuck.Viscoelastic residue was not observed to be distributed evenly throughout the cartridge indicating that an inadequate amount of ovd may have been used which could contribute to the complaint issue.The lens module was inspected and no issues or viscoelastic residue was identified.The plunger rod was observed to be bent.Device assembly was inspected and no issues were identified.Plunger rod advancement was inspected and no resistance was felt.The lens was removed from the cartridge, cleaned, and inspected revealing the lens to be torn and damaged.One haptic was observed to be damaged.Manufacturing record review: a review of the device history record (dhr) showed that the device met all specifications prior to being released.No device failure was identified.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by a surgeon that there a preloaded monofocal intraocular lenses (iol) had a bent tip.The lens was partially inserted.The issue was first identified during implantation.The patient status was fully recovered.No further information is available.

• Brand Name: TECNIS SIMPLICITY
• 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: 20776735
• Report Number: 3012236936-2024-000311
• Device Sequence Number: 12763604
• Product Code: HQL
• UDI-Device Identifier: 05050474636040
• UDI-Public: (01)05050474636040(17)260625
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: 06/25/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• 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: 10/31/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2023
• 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