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

Model Number	DCB00
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable, lens remains implanted in the eye.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that doctor saw some black remnants on an intraocular lens (iol) upon implantation.Additional information from follow-up response states surgeon has preserved on a card a piece of the fiber, doesn't know if it is visible if the tape is peeled off.At the time of surgery it was refractile, linear at most 0.1mm in diameter and about 2mm long.The iol was implanted after uncomplicated surgery and uncomplicated delivery of the iol into the anterior chamber.There were multiple fibers or spicules noted after the implantation into the anterior chamber.All were irrigated and aspirated from the eye.They were very uniform in size shape and color.The iol was allowed to remain in the eye and was placed into the capsular bag.Patient was referral patient and not feedback has been received on how the patient doing post-op.No further information provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.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.

• 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
• MDR Report Key: 11144180
• Report Number: 2648035-2021-07007
• Device Sequence Number: 16352949
• Product Code: HQL
• UDI-Device Identifier: 05050474635944
• UDI-Public: (01)05050474635944(17)221118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: No Information
• Device Expiration Date: 11/18/2022
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1